FDA Device recall Z-0862-2024
Senographe Pristina
- FDA Device
- Class II
- ongoing
- Published 2024-02-14
On 2024-02-14 the FDA classified a Class II recall of Senographe Pristina by Ge Medical Systems Scs, citing X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0862-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-26 |
| Published | 2024-02-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems Scs |
| Distribution | US |
Product
Senographe Pristina
Reason
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
Identifiers
| code_info | GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0862-2024%22
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