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October 20, 2021
Company: Draeger Medical, Inc. Date of Enforcement Report: 10/20/2021 Class II PRODUCT Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult, pediatric and neonatal patients. Catalog Number: 8416400 Recall Number: Z-0108-2022 REASON Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of...
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Company: BioMerieux SA Date of Enforcement Report: 10/20/2021 Class II PRODUCT MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System Recall Number: Z-0084-2022 REASON Under certain conditions, there is a risk for a false negative result. RECALLING FIRM/MANUFACTURER BioMerieux SA on 9/2/2021. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT...
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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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