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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86452

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

Open FDA event record

Event summary

Timeline bucket
September 08, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GE Healthcare, LLC

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

5 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 5

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Z-0127-2021
Recall number
Z-0127-2021
Initiated
September 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
30 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Code information

Model: 5741000 and 5741000-20

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

device · product 2 of 5

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Z-0128-2021
Recall number
Z-0128-2021
Initiated
September 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
30 devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Code information

Model: 5741000-23 and 5396469

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

device · product 3 of 5

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Z-0129-2021
Recall number
Z-0129-2021
Initiated
September 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
30 Devices total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Code information

Model: 5352293, 5726207-5, 5741000-25 and 5741000-29 .

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

device · product 4 of 5

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Z-0130-2021
Recall number
Z-0130-2021
Initiated
September 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
30 devices Total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Code information

Model: 5148810-3, 5741000-100, 5741000-26 and 5741000-27

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

device · product 5 of 5

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

Z-0131-2021
Recall number
Z-0131-2021
Initiated
September 08, 2020
Classification
Class II
Status
Terminated
Recalling firm
GE Healthcare, LLC
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

Code information

Model: 5726207-8 and 5741000-28

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.