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Recall Observatory FDA recall evidence

Device 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

Z-1249-2022

April 13, 2022

Class II

Product summary

Firm
Getinge Usa Sales Inc
Event
Event 90146
Status
Ongoing
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-1249-2022

Official wording

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

Code information: UDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247

Distribution pattern: US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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