Z-3118-2011

Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is...

Name: Z-3118-2011 Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is...
Creator: Steris Corporation
Published: 2011-05-09
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2011-05-09 / Terminated

FDA source

Steris Corporation began a recall of Reliance Vision Single Chamber Washer/Disinfector, Model # 1802983, The Vision Single Chamber Washer is intended for use in the cleaning and intermediate level... on 2011-05-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3118-2011
Status: Terminated
Initiated: 2011-05-09
Posted: 2011-09-01
Terminated: 2013-03-01
Recalling firm: STERIS Corporation
Product: 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 found in healthcare facilities.
Product code: MEC Disinfector, Medical Devices
Reason for recall: 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.
FDA 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 Washer(s). For further information or if you have questions regarding the servicing of your unit, please contact STERIS Field Service Dispatch at 1-800-333-8828.
Quantity in commerce: 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.
Product codes and lots: Model #: 1802983

Product code MEC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)