Recall Z-3118-2011 ยท MEC Disinfector, Medical Devices
Steris Corporation
Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments such as forceps and clamps, theatre shoes and other similar and related articles fou
| Date | Sep 1, 2011 (initiated May 9, 2011) |
| Status | Terminated |
| Reason | STERIS learned that Vision SC Washer users were experiencing nuisance alarms and/or aborted cycles that are adversely affecting the reliability and operation of their unit. |
| Root cause | Pending |
| Action | The firm, STERIS sent an "URGENT FIELD CORRECTION NOTICE" letter dated May 9, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed that they can continue using their Vision SC Washer(s) prior to installation of the system upgrades. The letter states that STERIS is correcting the issues by implementing a series of quality improvements to the customers Vision SC Washer(s) to ensure satisfaction. Additionally, a STERIS Service Representative will contact the customers facility to arrange for STERIS to upgrade their Vision SC |
| Quantity | 404 Units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: L, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI and WY; and countries of: Australia, Canada, Hong Kong and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.