Day

March 30, 2016
30
Mar

Cl II Siemens syngo X Workplace

March 30, 2016
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/30/2016 Class lI: PRODUCT syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional proceduress. Recall Number Z-1232-2016 REASON After...
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30
Mar

Cl II Roche cobas p 512 pre-analytical system

March 30, 2016
Company: Roche Diagnostics Operations, Inc. .Date of Enforcement Report 3/30/2016 Class lI: PRODUCT cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. Recall Number Z-1233-2016 REASON Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back...
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30
Mar

MHI-TM2000 Linear Accelerator System: Cl II

March 30, 2016
Company: MITSUBISHI HEAVY INDUSTRIES, LTD.,.Date of Enforcement Report 3/30/2016 Class lI: PRODUCT MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. Recall Number Z-1244-2016 REASON Due to Operator Console software anomaly, a change in treatment completion status of...
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30
Mar

Infusion Pump: Cl II Alaris PC Unit

March 30, 2016
Company: CareFusion 303 Inc..Date of Enforcement Report 3/30/2016 Class lI: PRODUCT Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092. Recall Number Z-1239-2016 REASON CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code (120.4630). RECALLING FIRM/MANUFACTURER CareFusion...
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IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

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IEC 81001-5-1 Cybersecurity Lifecycle

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IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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