GE Medical Systems, SCS Recall 93837
Description: Senographe Pristina
GE Medical Systems, SCS Recall 93837 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-0862-2024 |
| Event ID | 93837 |
| Event Description | Senographe Pristina |
| Product Type | Devices |
| Distribution | Us Nationwide-Worldwide Distribution |
| Quantity | 180 units (60 US; 120 OUS) |
| Recall Reason | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. |
| Device Classification | 20240214 |
| Device Code Info | GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879 |
| Center Classification Date | 20240208 |
| Recall Initiation Date | 20231226 |
| Recalling Firm | GE Medical Systems, SCS |
| Initial Notification | Letter |
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