Z-1289-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 6, 2022
- Initiation Date
- May 3, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 systems
Product Description
System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Reason for Recall
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.
Distribution Pattern
U.S.: CA, CO, FL, NY, and WY O.U.S.: None
Code Information
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