March 6, 2019
In January 2018, the U.S. Food and Drug Administration (FDA) issued a safety communication to alert health care providers and patients about a potential problem in the charging circuitry of the Zoll LifeVest 4000, which had the potential to prevent it from delivering a life-saving shock to patients. If the message “Call for Service –...
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Company: Elekta, Inc. Date of Enforcement Report: 2/8/2019 Class II: PRODUCT Monaco Radiation Treatment Planning (RTP) System Recall Number: Z-0965-2019 REASON If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan...
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Company: Shimadzu Medical Systems Usa Com Date of Enforcement Report: 3/6/2019 Class II: PRODUCT DIGITAL ANGIOGRAPHY SYSTEM: This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 3/6/2019 Class II: PRODUCT Sensis Vibe System, Model Number 11007642, with software version VD10B. Recall Number: Z-0936-2019 REASON A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed...
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Company: Physio-Control Inc Date of Enforcement Report: 3/6/2019 Class I: PRODUCT LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in...
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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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