FDAFDA · Food and drugs·Recall number Z-1289-2022
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Published July 6, 2022 · Recall initiated: May 3, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Canon Medical System, USA, INC.
- Distributor
- U.S.: CA, CO, FL, NY, and WY O.U.S.: None
- Lot
- UDI-DI Code: 04987670100192 Model Number: INFX-8000C/BF Serial Number/SID: BFA18Y7001 / 30038795 Model Number: INFX-8000C/BH Serial Number / SID: BHB2132002 / 30039730 BHB2132003/ 30039787 BHA1992001 / 30043325 BHC21X2004 / Not Provided Model Number: INFX-8000C/SW Serial Numbers/SID: SWB2162001 / 30052648
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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