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

Getinge Usa Sales Inc
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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