April 20, 2019
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...
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CSV Training Course

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

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