Reported Jul 6, 2022 · Ongoing
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH,…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- SystemAlphenix 4D CT in combination with
- CAS-930A (C arm Support) Model Number
INFX-8000C/BFINFX-8000C/BHINFX-8000C/SW
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published INFX-8000C/BFSerial Number/SID: BFA18Y7001 / 30038795 INFX-8000C/BHSerial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided INFX-8000C/SWSerial Numbers/SID: SWB2162001 / 30052648 - Amount recalled
- 6 systems
Where it was sold
Why it was recalled
CT operation may be restricted by an interlock which is a result of an system error and the CT system may stop operating properly after an attempt to cancel the error message has been initiated.
This product could cause temporary or reversible health problems — stop using it.
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