Recall – Washer/Disinfector software executes different cleaning cycle than selected

Company: Steris Corporation
Date of Enforcement Report: 3/20/2019
Class II:

PRODUCT

AMSCO 3000 Series Washer/Disinfector Model # 3052

Recall Number: Z-0995-2019

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.

RECALLING FIRM/MANUFACTURER

Steris Corporation on 12/20/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
11

DISTRIBUTION

US Nationwide and International

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.