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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82038

64 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 21, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems Nederlands

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

64 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 64

Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System

Z-0869-2019
Recall number
Z-0869-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 2 of 64

Prodiva CX, Model Number 781070. Nuclear Magnetic Resonance Imaging System

Z-0870-2019
Recall number
Z-0870-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 3 of 64

Multiva 1.5T 8 R5 (ZBO), Model Number 781072. Nuclear Magnetic Resonance Imaging System

Z-0871-2019
Recall number
Z-0871-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 4 of 64

Multiva 1.5T 16 R5 (ZBO), Model Number 781073. Nuclear Magnetic Resonance Imaging System

Z-0872-2019
Recall number
Z-0872-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 5 of 64

Multiva 1.5T 16 R5, Model Number 781078. Nuclear Magnetic Resonance Imaging System

Z-0873-2019
Recall number
Z-0873-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 6 of 64

Intera 0.5T Standard, Model Number 781101. Nuclear Magnetic Resonance Imaging System

Z-0874-2019
Recall number
Z-0874-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 7 of 64

Intera 1.0T Omni/Stellar, Model Number 781102. Nuclear Magnetic Resonance Imaging System

Z-0875-2019
Recall number
Z-0875-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 8 of 64

Intera 1.0T Power/Pulsar, Model Number 781103. Nuclear Magnetic Resonance Imaging System

Z-0876-2019
Recall number
Z-0876-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 9 of 64

Intera 1.5T Omni/Stellar, Model Number 781104. Nuclear Magnetic Resonance Imaging System

Z-0877-2019
Recall number
Z-0877-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 10 of 64

Intera 1.5T Power/Pulsar, Model Number 781105. Nuclear Magnetic Resonance Imaging System

Z-0878-2019
Recall number
Z-0878-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 11 of 64

Intera 1.5T Master/Nova, Model Number 781106. Nuclear Magnetic Resonance Imaging System

Z-0879-2019
Recall number
Z-0879-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 12 of 64

Intera 1.5T CV, Model Number 781107. Nuclear Magnetic Resonance Imaging System

Z-0880-2019
Recall number
Z-0880-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 13 of 64

Intera 1.5T Explorer/Nova Dual, Model Number 781108. Nuclear Magnetic Resonance Imaging System

Z-0881-2019
Recall number
Z-0881-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 14 of 64

Enterprise 1.5T, Model Number 781145. Nuclear Magnetic Resonance Imaging System

Z-0882-2019
Recall number
Z-0882-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 15 of 64

Intera 3.0T Master/Quasar Dual, Model Number 781150. Nuclear Magnetic Resonance Imaging System

Z-0883-2019
Recall number
Z-0883-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 16 of 64

Achieva XR 1.5T/3.0T, Model Number 781153. Nuclear Magnetic Resonance Imaging System

Z-0884-2019
Recall number
Z-0884-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 17 of 64

Intera IT, Model Number 781160. Nuclear Magnetic Resonance Imaging System

Z-0885-2019
Recall number
Z-0885-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 18 of 64

Intera 1.5T R11, Model Number 781170. Nuclear Magnetic Resonance Imaging System

Z-0886-2019
Recall number
Z-0886-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 19 of 64

Intera Achieva 1.5T Pulsar, Model Number 781171. Nuclear Magnetic Resonance Imaging System

Z-0887-2019
Recall number
Z-0887-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 20 of 64

Intera Achieva 1.5T Nova, Model Number 781172. Nuclear Magnetic Resonance Imaging System

Z-0888-2019
Recall number
Z-0888-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 21 of 64

Intera Achieva 1.5T Nova Dual, Model Number 781173. Nuclear Magnetic Resonance Imaging System

Z-0889-2019
Recall number
Z-0889-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 22 of 64

Intera 1.5T Achieva CV Nova, Model Number 781174. Nuclear Magnetic Resonance Imaging System

Z-0890-2019
Recall number
Z-0890-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 23 of 64

Intera Achieva 1.5T IT Nova, Model Number 781175. Nuclear Magnetic Resonance Imaging System

Z-0891-2019
Recall number
Z-0891-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 24 of 64

Intera Achieva 1.5T IT Nova Dual, Model Number 781176. Nuclear Magnetic Resonance Imaging System

Z-0892-2019
Recall number
Z-0892-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 25 of 64

Achieva 3.0T, Model Number 781177. Nuclear Magnetic Resonance Imaging System

Z-0893-2019
Recall number
Z-0893-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 26 of 64

Achieva 1.5T, Model Number 781178. Nuclear Magnetic Resonance Imaging System

Z-0894-2019
Recall number
Z-0894-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 27 of 64

Intera 1.5T, Model Number 781195. Nuclear Magnetic Resonance Imaging System

Z-0895-2019
Recall number
Z-0895-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 28 of 64

Achieva 1.5T High Performance, Model Number 781196. Nuclear Magnetic Resonance Imaging System

Z-0896-2019
Recall number
Z-0896-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 29 of 64

Achieva 7.0T, Model Number 781240. Nuclear Magnetic Resonance Imaging System

Z-0897-2019
Recall number
Z-0897-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 30 of 64

Panorama 1.0T, Model Number 781250. Nuclear Magnetic Resonance Imaging System

Z-0898-2019
Recall number
Z-0898-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 31 of 64

Achieva XR 1.5T/3.0T , Model Number 781253. Nuclear Magnetic Resonance Imaging System

Z-0899-2019
Recall number
Z-0899-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 32 of 64

SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resonance Imaging System

Z-0900-2019
Recall number
Z-0900-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 33 of 64

Ingenia 1.5T CX, Model Number 781261. Nuclear Magnetic Resonance Imaging System

Z-0901-2019
Recall number
Z-0901-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 34 of 64

Ingenia 1.5T CX (ZBO), Model Number 781262. Nuclear Magnetic Resonance Imaging System

Z-0902-2019
Recall number
Z-0902-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 35 of 64

SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic Resonance Imaging System

Z-0903-2019
Recall number
Z-0903-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 36 of 64

Ingenia 3.0T CX, Model Number 781271. Nuclear Magnetic Resonance Imaging System

Z-0904-2019
Recall number
Z-0904-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 37 of 64

Achieva 3.0T X-series, Model Number 781277. Nuclear Magnetic Resonance Imaging System

Z-0905-2019
Recall number
Z-0905-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 38 of 64

Achieva 3.0T TX-series, Model Number 781278. Nuclear Magnetic Resonance Imaging System

Z-0906-2019
Recall number
Z-0906-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 39 of 64

Achieva 1.5T Conversion, Model Number 781283. Nuclear Magnetic Resonance Imaging System

Z-0907-2019
Recall number
Z-0907-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 40 of 64

Intera 1.5T High Performance, Model Number 781295. Nuclear Magnetic Resonance Imaging System

Z-0908-2019
Recall number
Z-0908-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 41 of 64

Achieva 1.5T, Model Number 781296. Nuclear Magnetic Resonance Imaging System

Z-0909-2019
Recall number
Z-0909-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 42 of 64

Ingenia 1.5T, Model Number 781341. Nuclear Magnetic Resonance Imaging System

Z-0910-2019
Recall number
Z-0910-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 43 of 64

Ingenia 3.0T, Model Number 781342. Nuclear Magnetic Resonance Imaging System

Z-0911-2019
Recall number
Z-0911-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 44 of 64

Achieva 1.5T, Model Number 781343. Nuclear Magnetic Resonance Imaging System

Z-0912-2019
Recall number
Z-0912-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 45 of 64

Achieva 3.0T X, Model Number 781344. Nuclear Magnetic Resonance Imaging System

Z-0913-2019
Recall number
Z-0913-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 46 of 64

Achieva 3.0T TX, Model Number 781345. Nuclear Magnetic Resonance Imaging System

Z-0914-2019
Recall number
Z-0914-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 47 of 64

Achieva 1.5T Conversion, Model Number 781346. Nuclear Magnetic Resonance Imaging System

Z-0915-2019
Recall number
Z-0915-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 48 of 64

Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System

Z-0916-2019
Recall number
Z-0916-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 49 of 64

Panorama 1.0T, Model Number 781350. Nuclear Magnetic Resonance Imaging System

Z-0917-2019
Recall number
Z-0917-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 50 of 64

Ingenia 3.0T, Model Number 781377. Nuclear Magnetic Resonance Imaging System

Z-0918-2019
Recall number
Z-0918-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 51 of 64

Ingenia 1.5T, Model Number 781396. Nuclear Magnetic Resonance Imaging System

Z-0919-2019
Recall number
Z-0919-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 52 of 64

Ingenia Ambition S, Model Number 781359. Nuclear Magnetic Resonance Imaging System

Z-0920-2019
Recall number
Z-0920-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 53 of 64

Ingenia Ambition X, Model Number 781356. Nuclear Magnetic Resonance Imaging System

Z-0921-2019
Recall number
Z-0921-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 54 of 64

Ingenia Elition S, Model Number 781357. Nuclear Magnetic Resonance Imaging System

Z-0922-2019
Recall number
Z-0922-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 55 of 64

Ingenia Elition X, Model Number 781358. Nuclear Magnetic Resonance Imaging System

Z-0923-2019
Recall number
Z-0923-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 56 of 64

MR-OR 1.5T, Model Number 781437. Nuclear Magnetic Resonance Imaging System

Z-0924-2019
Recall number
Z-0924-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 57 of 64

MR-OR 3.0T, Model Number 781438. Nuclear Magnetic Resonance Imaging System

Z-0925-2019
Recall number
Z-0925-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 58 of 64

MR RT, Model Number 781439. Nuclear Magnetic Resonance Imaging System

Z-0926-2019
Recall number
Z-0926-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 59 of 64

Achieva 3.0T for PET, Model Number 781477. Nuclear Magnetic Resonance Imaging System

Z-0927-2019
Recall number
Z-0927-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 60 of 64

Achieva 3.0T TX for PET, Model Number 781479. Nuclear Magnetic Resonance Imaging System

Z-0928-2019
Recall number
Z-0928-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 61 of 64

NZM101 Ingenia 1.5T Linac, Model Number 781483. Nuclear Magnetic Resonance Imaging System

Z-0929-2019
Recall number
Z-0929-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 62 of 64

MARLIN 1.5T, Model Number 781474. Nuclear Magnetic Resonance Imaging System

Z-0930-2019
Recall number
Z-0930-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 63 of 64

Multiva 1.5T 8 R5, Model Number 781074. Nuclear Magnetic Resonance Imaging System

Z-0931-2019
Recall number
Z-0931-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.

device · product 64 of 64

Multiva 1.5T, Model Number 781076. Nuclear Magnetic Resonance Imaging System

Z-0932-2019
Recall number
Z-0932-2019
Initiated
December 21, 2018
Classification
Class II
Status
Terminated
Quantity
11226 total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

Code information

All systems

Distribution pattern

U.S. Nationwide distribution.