May 1, 2019

May

Recall – Continuous Autotransfusion System sequence of errors leads to excessive wear

May 1, 2019Jordan PateNews

Company: Fenwal Inc. Date of Enforcement Report: 5/1/2019 Class II PRODUCT Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set,...

May

Recall – IVD software error detection inadvertently disabled

May 1, 2019Jordan PateNews

Company: Ortho-Clinical Diagnostics Date of Enforcement Report: 5/1/2019 Class II PRODUCT VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides,...

May

Recall – Digital Linear Accelerator software error may lead to injury

May 1, 2019Jordan PateNews

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 5/1/2019 Class II: PRODUCT Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control...

May

Recall – Radiation treatment planning app may lead to incorrect dose calculation

May 1, 2019Jordan PateNews

Company: Brainlab AG Date of Enforcement Report: 5/1/2019 Class II: PRODUCT RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: – Cranial SRS 1.0.0 and 1.5.0 – Spine SRS 1.0.0 and 1.5.0 – Multiple Brain Mets SRS 1.5.0 – RT QA...

May

Recall – Insertable Cardiac Monitor unable to pair with mobile app

May 1, 2019Jordan PateNews

Company: St Jude Medical Inc. Date of Enforcement Report: 5/1/2019 Class II: PRODUCT St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated...

Recall – Continuous Autotransfusion System sequence of errors leads to excessive wear

Recall – IVD software error detection inadvertently disabled

Recall – Digital Linear Accelerator software error may lead to injury

Recall – Radiation treatment planning app may lead to incorrect dose calculation

Recall – Insertable Cardiac Monitor unable to pair with mobile app

SoftwareCPR Training Courses

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Day

Recall – Continuous Autotransfusion System sequence of errors leads to excessive wear

Recall – IVD software error detection inadvertently disabled

Recall – Digital Linear Accelerator software error may lead to injury

Recall – Radiation treatment planning app may lead to incorrect dose calculation

Recall – Insertable Cardiac Monitor unable to pair with mobile app

SoftwareCPR Training Courses

Corporate Office