Canon Medical System, USA, INC. Recall 90246
Description: System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW
Canon Medical System, USA, INC. Recall 90246 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1289-2022 |
| Event ID | 90246 |
| Event Description | System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW |
| Product Type | Devices |
| Distribution | U.S.: CA, CO, FL, NY, and WY O.U.S.: None |
| Quantity | 6 systems |
| Recall Reason | 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. |
| Device Classification | 20220706 |
| Device Code Info | 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 |
| Center Classification Date | 20220624 |
| Recall Initiation Date | 20220503 |
| Recalling Firm | Canon Medical System, USA, INC. |
| Initial Notification | Letter |
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