Day

April 5, 2017
Company: Medtronic Neuromodulation Date of Enforcement Report 4/5/2017 Class lI: PRODUCT SynchroMed II implantable drug infusion pump, Model 8637-40, Recall Number Z-1694-2017 REASON Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from...
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Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 4/5/2017 Class lI: PRODUCT Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-1688-2017 REASON Software changes now available to address several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...
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Company: Siemens Medical Solutions USA, IncDate of Enforcement Report 4/5/2017 Class lI: PRODUCT Syngo.via Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Recall Number Z-1689-2017 REASON Software changes now available to address several issues RECALLING FIRM/MANUFACTURER Siemens Medical Solutions...
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Company:Respironics California Inc, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED ENGL OPT:CFLEX, AVAPS,PPV,AT+cl V60 VENT, JAPAN OPT: CFLEX,...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data Recall Number Z-1697-2017 REASON The study is archived but cannot be opened in iConnect Access and cannot...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT iConnect Enterprise Archive software Recall Number Z-1700-2017 REASON The versions allow images to be stored without pixel data, resulting in the system not being able to present all the prior studies, which could cause a delay in treatment in determining the progression of...
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Company: Hospira, Inc. Date of Enforcement Report 4/5/2017 Class lI: PRODUCT Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions Recall Number Z-1682-2017 REASON Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy...
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The EU MDR of April, 5, 2017 is at the link below.  Clause (19) states: “It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a...
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This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

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