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Recall Observatory FDA recall evidence

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

January 16, 2020

Class III

Product summary

Firm
Maquet Cardiovascular Us Sales, Llc
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

    reason.no_named_rule · v1.0.0

    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.