CLASS II Device recall · Reported 15 Apr 2015 · FDA Enforcement Report

Infx-8000V Interventional Angiography System recalled

Toshiba American Medical Systems is recalling Infx-8000V Interventional Angiography System, distributed nationwide in the US. The recall was initiated on 11 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. U7E1462009, ACA1472001, UEB1352004, UFD1442017, AAA1492001, ACA1492002, ULD1412014, AHA1482001, UPB1372006, ULD1392013, U6A1472001, ULD1452016, UPB1352005, ULD1452015, UDE1352017, A4B1472002, U4A14X2001, UPB1342004, 99B1342133, 99B1342134, UFD1452018, UFD13X2015, UFD13X2016, UFD1362014, UUC1452012, A6A1492002, UUC13Z2011, AAA14X2002, A4A13Z2001.

Quantity recalled28 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-1394-2015
FDA event ID: 70748
Recalling firm: Toshiba American Medical Systems, Tustin, CA
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2015
FDA classified: 6 Apr 2015
Reported: 15 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

11 Mar 2015	Recall initiated by company
6 Apr 2015	Classified by FDA	+26 days
15 Apr 2015	Published in enforcement report	+9 days

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

Reason for recall

The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.

Which lots are affected?

Serial No. U7E1462009, ACA1472001, UEB1352004, UFD1442017, AAA1492001, ACA1492002, ULD1412014, AHA1482001, UPB1372006, ULD1392013, U6A1472001, ULD1452016, UPB1352005, ULD1452015, UDE1352017, A4B1472002, U4A14X2001, UPB1342004, 99B1342133, 99B1342134, UFD1452018, UFD13X2015, UFD13X2016, UFD1362014, UUC1452012, A6A1492002, UUC13Z2011, AAA14X2002, A4A13Z2001.

Where was it sold?

Nationwide Distribution

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 26 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-8000F 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

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide