Getinge CM320 WUWD Washer Disinfector Installation Verification Issue Recall
The FDA is recalling 11 Getinge CM320 WUWD washer-disinfectors used for surgical instrument processing. Installation verification was not properly documented or completed, potentially creating risks of electrical shock, burns, and other injuries.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving serious potential hazards—electrical shock, burns, and crush injuries—but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without confirmed injuries score 3 (High).
Plain-English summary
Getinge Usa Sales Inc is recalling 11 units of the Getinge CM320 WUWD Series Washer Disinfector, a multi-chamber medical device used to wash, disinfect, and dry surgical instruments.
The recall was initiated because verification of proper installation was not documented or may be incomplete. Incomplete or improper installation could create serious user hazards, including electrical shock, skin burns, smoke inhalation, crush or pinch injuries, and slip and fall accidents. Installation issues could also lead to patient procedural delays and infection risks.
The affected units are distributed across Maryland, Minnesota, North Dakota, Nebraska, New York, Pennsylvania, and Virginia. Specific serial numbers have been identified by the manufacturer and are available from the FDA.
Facilities operating any of these units should verify their installation documentation and contact Getinge Usa Sales Inc or the FDA for guidance if they believe their facility may be affected.
The recalled product
- Product
- 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
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- electrical-shock
- burn-injury
- crush-injury
- slip-fall
- smoke-inhalation
- infection-risk
Distribution
Distributed nationwide across the United States.
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