FDA Device recall Z-1249-2022
Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgica…
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgica… by Getinge Usa Sales, citing verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1249-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Getinge Usa Sales |
| Distribution | US |
Product
Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
Reason
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Identifiers
| code_info | UDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1249-2022%22
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