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
Check against the official notice below — it lists the full affected range.
Getinge USA Sales Inc. is recalling 11 units of the Getinge CM320 WUWD Series Washer Disinfector, a device used to wash, disinfect, and dry surgical instruments. The recall affects units distributed nationwide in Maryland, Minnesota, North Dakota, Nebraska, New York, Pennsylvania, and Virginia. The problem is that verification of installation for these units may not have been documented or completed properly.
The incomplete installation verification could result in harm to users, including skin burns, smoke inhalation, electric shock, crush or pinch injuries, or slip and fall injuries. Additionally, the issue may lead to patient procedural delays or infections. The affected serial numbers are: W50026718, W50029991, WAA081312, W50039234, WAA062340, WAA062341, WAA070619, WAA085063, WAA089556, WAA093936, and WAA094247. The source document does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: US Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA. Quantity: 11 units Lot/code info: UDI-DI: 07340153700192 Serial Numbers: W50026718 W50029991 WAA081312 W50039234 WAA062340 WAA062341 WAA070619 WAA085063 WAA089556 WAA093936 WAA094247
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.