FDA Device recall Z-2133-2025
SIGNA PET/MR
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of SIGNA PET/MR by Ge Medical Systems, citing GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic nois….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2133-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-23 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
Product
SIGNA PET/MR
Reason
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.
Identifiers
| code_info | GTIN: 00840682105378 |
|---|
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-2133-2025%22
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