Z-1289-2022 Class II Ongoing
FDA device recall Z-1289-2022 was initiated by Canon Medical System, USA, INC. on May 3, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6 systems.
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