November 25, 2020
Company: Mako Surgical Corporation Date of Enforcement Report: 11/25/2020 Class II PRODUCT Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 – Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register...
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Company: Roche Diagnostics Operations, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001 Recall Number: Z-0461-2021 REASON Potential incorrect validation of results due to...
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Company: LivaNova USA Inc Date of Enforcement Report: 11/25/2020 Class II PRODUCT VNS Therapy AspireSR Generator Recall Number: Z-0462-2021 REASON Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. RECALLING FIRM/MANUFACTURER LivaNova USA Inc...
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Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report: 11/25/2020 Class II PRODUCT Atellica IM 1300 Analyzer – Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 Recall Number: Z-0473-2021 REASON Test Definition scanning may reset custom settings to defaults causing falsely low or...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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