May 18, 2016
Company: Novarad Corporation Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation Recall Number Z-1613-2016 REASON IThe SUV values that are being calculated in the PET/CT fusion tool are incorrect. RECALLING FIRM/MANUFACTURER Novarad Corporation, American fork, UT on 11/16/2015. Voluntary: Firm Initiated recall is ongoing....
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Company: Neusoft Medical Systems Co., Ltd. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i) Recall Number Z-1650-2016 REASON It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of...
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The US FDA issued a draft guidance entitled: “Use of Electronic Health Record Data in Clinical Investigations”. This draft addresses a variety of issues including EHRs certified by ONC, data modifications, audit trials, informed consent, and Privacy and Security. The full draft guidance can be found at the following link: FDA_Use_of_EHR_Data_in_Clinical_Investigations
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Company: Medtronic Date of Enforcement Report 5/18/2016 Class lI: PRODUCT Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and acute care settings.. Recall Number Z-1648-2016 REASON Kangaroo Connect Feeding Pump Occlusion alarms fail to alarm RECALLING FIRM/MANUFACTURER Medtronic, North Haven, CT on 4/1/2016....
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Company: Acusom US Inc. Date of Enforcement Report 5/18/2016 Class lI: PRODUCT Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0). Recall Number Z-1638-2016 REASON Due to a malfunction of software, the secondary module will not automatically take over messaging if the primary module fails after a...
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SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

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  • Software risk analysis
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  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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