Day

March 4, 2015
Company: GE Healthcare It. Date of Enforcement Report 3/4/2015 Class lI: PRODUCT The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare...
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Company:Spacelabs Healthcare Inc.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393,...
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Company:Spacelabs Healthcare Inc.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays,...
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Company:Iba Dosimetry Gmbh.Date of Enforcement Report: 3/4/2015 Class lI: PRODUCT COMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiological. Recall Number Z-1212-2015 REASON Error in the software. During internal tests of the current development version of the Compass SW it was found that dose reconstruction for DMLC plans when the jaws move or...
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ANSI/AAMI/IEC TIR80001-2-5:2014 “Application of risk management for IT-networks incorporating medical devices Part 2-5: Application guidance: Guidance on distributed alarm systems” has been published. Sherman Eagles of SoftwareCPR was a co-chair for this.
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