CLASS II Device recall · Reported 14 Mar 2018 · FDA Enforcement Report

Infx-8000F Fluoroscopic X-Ray Systems recalled

Toshiba American Medical Systems is recalling Infx-8000F Fluoroscopic X-Ray Systems. The recall was initiated on 29 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003

Quantity recalled17 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0842-2018
FDA event ID: 79153
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 29 Dec 2017
FDA classified: 2 Mar 2018
Reported: 14 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

29 Dec 2017	Recall initiated by company
2 Mar 2018	Classified by FDA	+63 days
14 Mar 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

INFX-8000F Fluoroscopic X-Ray Systems

Where it was distributed

United States

Questions about this recall

Is Infx-8000F Fluoroscopic X-Ray Systems recalled?

Yes. Toshiba American Medical Systems recalled Infx-8000F Fluoroscopic X-Ray Systems on 29 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-0842-2018.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

United States

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Toshiba American Medical Systems

All 57

Reported	Class	Recall	Company	Reason	Where
4 Jul 2018Device	CLASS II	Diagnostic Ultrasound System, Aplio I-series recalled	Toshiba American Medical Systems	Device Malfunction	Nationwide
14 Mar 2018Device	CLASS II	Infx-8000V Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000H Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
14 Mar 2018Device	CLASS II	Infx-8000C Fluoroscopic X-Ray Systems recalled	Toshiba American Medical Systems	Other	CA
25 Oct 2017Device	CLASS II	Toshiba Medical Kalare Fluoroscopic X-Ray System recalled	Toshiba American Medical Systems	Other	Nationwide

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