October 18, 2018
Company: GE Healthcare, LLC Date of Enforcement Report: 10/24/2018 Class II: PRODUCT Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. Recall Number: Z-0195-2019 REASON Remote comparison studies displayed may be associated with the wrong patient, without a caution icon present. RECALLING FIRM/MANUFACTURER GE Healthcare, LLC, Waukesha, WI on...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 10/24/2018 Class II: PRODUCT Atellica Sample Handler Prime (SMN 11069001). The Atellica” Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. Recall Number: Z-0189-2019 REASON Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock...
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