Recall Z-0018-2014— Getinge Disinfection
Class II · Terminated
Class II FDA medical device recall by Getinge Disinfection, initiated 2013-07-30, terminated 2015-05-11. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Getinge Disinfection
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-30
- Terminated
- 2015-05-11
- Firm location
- Vaxjo, Sweden
Product description
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 for recall
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.