FDA-Device2022-06-15Class II

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

Hazard

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

Sold states
US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.
Affected count
4 units
Manufactured in
1 Geoffrey Way, Wayne, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1248-2022

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