Recall Z-0995-2019 ยท MEC Disinfector, Medical Devices
Steris Corporation
AMSCO 3000 Series Washer/Disinfector Model # 3052
| Date | Dec 20, 2018 |
| Status | Terminated |
| Reason | The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers. |
| Quantity | 11 |
| Distribution | The products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, an |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.