Company:Boston Scientific Corporation.Date of Enforcement Report 11/15/2017 Class lI: PRODUCT RESONATE EL ICD VR, Model D432, Sterile. Recall Number Z-0077-2018 REASON The devices have an incorrect firmware configuration. RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Saint Paul, MN. on 10/4/2017. Voluntary: Firm Initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 5 devices DISTRIBUTION The devices were...Read More
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