February 25, 2015
Company:CME America, LLC.Date of Enforcement Report: 2/25/2015 Class lI: PRODUCT BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP Recall Number Z-1126-2015 REASON CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery. RECALLING FIRM/MANUFACTURER CME America, LLC, Golden, CO on 1/16/2015 Voluntary: Firm...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 2/25/2015 Class lI: PRODUCT Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose...
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Company:Alivecor SFO.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG...
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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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