Device product
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Z-1390-2020
Product summary
- Event
- Event 84885
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1390-2020
Official wording
Reason: Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
Code information: Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031
Distribution pattern: U.S. Distribution: CA, CO, IA, MN, NY, SC, VA
Derived failure modes
-
Unknown
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.