July 31, 2019
Company: Medical Intelligence Medizintechnik Gmbh Date of Enforcement Report: 7/31/2019 Class II PRODUCT IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. Recall Number: Z-2082-2019 REASON Sometimes, although the...
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Company: Merge Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 Recall Number: Z-2062-2019 REASON Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation...
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Company: GE Healthcare, LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT MAC VU360, Model Number 2030360-001, Electrocardiograph Recall Number: Z-2060-2019 REASON Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report...
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Company: Stanley Security Solutions Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT STANLEY Healthcare Arial 54315 Network Manager Recall Number: Z-1996-2019 REASON STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway. RECALLING FIRM/MANUFACTURER Stanley Security Solutions Inc...
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Company: GETINGE US SALES LLC Date of Enforcement Report: 7/31/2019 Class II PRODUCT PulsioFlex Monitoring System, Part Number: 6882747, Model Number: PC400 3 R0. Usage: The PulsioFlex Monitoring System is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. If a patient s biometric data are entered, the PulsioFlex Monitor presents the...
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Company: Spacelabs Healthcare, Inc. Date of Enforcement Report: 7/31/2019 Class II PRODUCT Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2. Recall Number: Z-2035-2019 REASON Several reports were received that patient records were printed with the correct patient demographics but containing another patient’s waveforms. RECALLING FIRM/MANUFACTURER Spacelabs Healthcare,...
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Company: Philips Medical Systems (Cleveland) Inc Date of Enforcement Report: 7/31/2019 Class II PRODUCT BrightView SPECT, Model Number 882480 Recall Number: Z-2009-2019 REASON An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released. RECALLING FIRM/MANUFACTURER Philips Medical Systems (Cleveland) Inc. on 6/10/2019. Voluntary:  Firm Initiated...
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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

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