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
Check against the official notice below — it lists the full affected range.
Getinge Usa Sales Inc is recalling the Getinge CM320-2 CHAMBER WU Series Washer Disinfector, a multi-chamber device used for washing, disinfecting, and drying surgical instruments. The recall affects four units with serial numbers W50034570, WAA070170, WAA070618, and WAA081312, distributed nationwide in Maryland, Minnesota, North Dakota, Nebraska, New York, Pennsylvania, and Virginia. The devices are being recalled because installation verification was not documented or may be incomplete.
The incomplete or unverified installation could result in serious injuries to users including skin burns, smoke inhalation, electric shock, crush or pinch injuries, or slip and fall incidents. Additionally, the installation issues may lead to delayed patient procedures or infections. The source document does not specify what actions affected consumers should take in response to this recall.
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: 4 units Lot/code info: UDI-DI: 07340153700185 Serial Numbers: W50034570 WAA070170 WAA070618 WAA081312
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.