Company:Medtronic Neuromodulation Date of Enforcement Report 3/8/2017 Class l PRODUCT Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N’Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Recall Number Z-0788-2017 REASON Medtronic is following...Read More
Company: Mckesson Medical Imaging Date of Enforcement Report 3/8/2017 Class lI: PRODUCT McKesson Radiology 12.2 – Picture Archive Communication System (PACS). Recall Number Z-1245-2017 REASON Issue for customers that use an EMR login or legacy web URL login or legacy web URL login for McKesson Radiology PACS that may result in missing images in a...Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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