Recall Z-1078-2022 ยท MEC Disinfector, Medical Devices
Getinge Usa Sales Inc
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
| Date | Apr 1, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Other |
| Action | An Urgent Medical Device Notification was issued 04/01/2022 via FedEx which includes serial numbers for affected devices. Customers are to verify they have an affected device and submit the attached Response Form. Distributors are to forward notification on to customers. Getinge service technicians will contact customers to schedule corrective actions. You can continue to use the Getinge Series 9100E-series Washer Disinfector with G1 control systems until the corrective action is performed, there are no precautionary actions necessary. Contact your Getinge representative with questions or for |
| Quantity | 127 |
| Distribution | Worldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, SD, TX, VA, WA, WV. (OUS) Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Kuwait, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.