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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79153

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

Open FDA event record

Event summary

Timeline bucket
December 29, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Toshiba American Medical Systems Inc

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

4 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 4

INFX-8000F Fluoroscopic X-Ray Systems

Z-0842-2018
Recall number
Z-0842-2018
Initiated
December 29, 2017
Classification
Class II
Status
Terminated
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Code information

Serial Numbers: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003

Distribution pattern

United States

device · product 2 of 4

INFX-8000C Fluoroscopic X-Ray Systems

Z-0843-2018
Recall number
Z-0843-2018
Initiated
December 29, 2017
Classification
Class II
Status
Terminated
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Code information

Serial Numbers: U6A1472001, UWB1422001, U6C13Y2007, A3A14Z2001, A6B1532003, A1B1552001, A6B1582004, A9B1622002, A9A1592001, A5C1622001, A6B1682005, A6B16X2006, A5C16Y2002, A1D1752002, AFA1662001, A9B1722003, A6B1742007, A6A1492002, A4B1472002

Distribution pattern

United States

device · product 3 of 4

INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

Z-0844-2018
Recall number
Z-0844-2018
Initiated
December 29, 2017
Classification
Class II
Status
Terminated
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Code information

Serial Numbers: UFD13X2015, UFD13X2016, UUC13Z2011, UEC1422013, UFD1442017, UFD1452018, AAA1642005, UUC1452012, UTC14Y2008, ACA1472001, ACA1492002, AAA1492001, AAA14X2002, A8A1532001, A9A1542001, AAA1542003, A9A1582002, ABB1627001, ACB1622003, A9A1662003, AAA1692006, A9A16X2004, A8B16Y2002, A7B16Y2001, ACB16Y2004, AAA1632004, AAA1712007, W4B1622031, W4B14Y2023

Distribution pattern

United States

device · product 4 of 4

INFX-8000H Fluoroscopic X-Ray Systems

Z-0845-2018
Recall number
Z-0845-2018
Initiated
December 29, 2017
Classification
Class II
Status
Terminated
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Code information

Serial Numbers: A5B1672001, AFA1692002

Distribution pattern

United States