Day

June 5, 2019
Company: Abbott Laboratories Inc. (St Jude Medical) Date of Enforcement Report: 6/5/2019 Class II PRODUCT TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400 Part Numbers: 600043767 (China), 100154367 (Global), 100154368 (SWAP) Recall Number: Z-1493-2019 REASON In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the...
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Company: Change Healthcare Israel Ltd. Date of Enforcement Report: 6/5/2019 Class II PRODUCT Horizon Cardiology Hemo: Software version 11.x and 12.x Recall Number: Z-1489-2019 Software version 13.x Recall Number: Z-1490-2019 REASON Users are not notified of procedure medication discrepancies between the Vitals and Meds, the Procedure Notes and Patient Common Data screens in Horizon/McKesson Cardiology...
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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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