Recall Z-1078-2022— Getinge Usa Sales Inc
Class II · Ongoing
Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2022-04-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.. Reason: Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations..
- Recalling firm
- Getinge Usa Sales Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-01
- Firm location
- Wayne, NJ, United States
Product description
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Reason for recall
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
Data sourced from openFDA. This site is unofficial and independent of the FDA.