FDA Device recall Z-0018-2014
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities whe…
- FDA Device
- Class II
- terminated
- Published 2013-10-23
On 2013-10-23 the FDA classified a Class II recall of Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities whe… by Getinge Disinfection, citing getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0018-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-30 |
| Published | 2013-10-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Getinge Disinfection |
| Distribution | US |
Product
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Reason
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Identifiers
| code_info | Model # 46-4, Serial # range SEV0521184-SEV0838137 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0018-2014%22
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