Toshiba INFX-8000V Interventional Angiography System Recall for Brake Defect
Toshiba is recalling 28 INFX-8000V Interventional Angiography Systems because the table base rotational brake may not engage when force is applied to the table top.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical defect in a medical device that could lead to injury if the table moves unexpectedly, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems Inc is recalling 28 units of the INFX-8000V Interventional Angiography System, which includes the CAT-880B catheterization table. The system is used for cardiac and vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada, the system is registered as Infinix CF-i or Infinix VF-i.
The recall is due to a defect in the table base rotational brake. The brake, which holds the table top, may not always be engaged when any force or side impact is applied to the table top. This issue could potentially allow the table to move unexpectedly during use.
The affected units were distributed nationwide. Specific serial numbers are listed in the official recall notice. Healthcare facilities should contact Toshiba American Medical Systems Inc for instructions on how to address this defect.
The recalled product
- Product
- 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…
- Manufacturer
- Toshiba American Medical Systems Inc
- Affected units
- 28
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial No. U7E1462009
- ACA1472001
- UEB1352004
- UFD1442017
- AAA1492001
- ACA1492002
- ULD1412014
- AHA1482001
- UPB1372006
- ULD1392013
- U6A1472001
- ULD1452016
- UPB1352005
- ULD1452015
- UDE1352017
- A4B1472002
- U4A14X2001
- UPB1342004
- 99B1342133
- 99B1342134
Distribution
Distributed nationwide across the United States.
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