Day

August 24, 2016
Company: Toshiba American Medical Systems Date of Enforcement Report 8/24/2016 Class lI: PRODUCT Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. Recall Number Z-2542-2016 REASON Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error. RECALLING FIRM/MANUFACTURER Toshiba American...
Read More
Company: Ortho-Clinical Diagnostics Date of Enforcement Report 8/24/2016 Class lI: PRODUCT ORTHO ProVue Analyzers; Product Code MTS213784; Unique Device Identifier (GTIN) 10758750006014 Recall Number B-0686-16 REASON ORTHO ProVue Analyzers, with suboptimal reference images and/or Brillo values outside of specification, were distributed. RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY on 6/14/2016. Voluntary: Firm Initiated recall is ongoing....
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 8/24/2016 Class lI: PRODUCT Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications , and media interchange of medical images from a variety of diagnostic imaging systems. Recall Number Z-2551-2016...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 8/24/2016 Class lI: PRODUCT iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. Recall Number Z-2532-2016 REASON Studies that are viewed in iConnect Access that originate on...
Read More
Company: Merge Healthcare, Inc. Date of Enforcement Report 8/24/2016 Class lI: PRODUCT iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. Recall Number Z-2531-2016 REASON Studies that are viewed in iConnect Access that originate on...
Read More
Company: Ge Healthcare ItDate of Enforcement Report 8/24/2016 Class lI: PRODUCT GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the...
Read More
Company: AB Sciex Date of Enforcement Report 8/24/2016 Class lI: PRODUCT AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the...
Read More
Company: AB Sciex Date of Enforcement Report 8/24/2016 Class lI: PRODUCT AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound...
Read More
Company: AB Sciex Date of Enforcement Report 8/24/2016 Class lI: PRODUCT AB Sciex API 3200MD” LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.