Device product
Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
Z-1248-2022
Product summary
- Event
- Event 90146
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1248-2022
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: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312
Distribution pattern: US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Derived failure modes
-
Unknown
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