Company: WalkMed Infusion LLC Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000)The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution. Recall Number Z-2219-2016 REASON WalkMed Infusion, LLC Announces a...Read More
Company: Toshiba America Medical Systems Inc. Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System Recall Number Z-2188-2016 REASON During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found...Read More
Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images Recall Number Z-2245-2016 REASON Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018/16/P to resolve software errors....Read More
Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report 7/27/2016 Class lI: PRODUCT RayStation 3.0, RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7 and RayStation 5 — Radiation Therapy Treatment Planning System — designed for treatment planning and analysis of radiation therapy, provides treatment unit set up parameters and estimates dose distributions. Recall Number Z-2206-2016 REASON...Read More
Company: Bayer Healthcare Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to...Read More
Company: Carestream Health Inc Date of Enforcement Report 7/27/2016 Class lI: PRODUCT Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 1738822 — Common Name: Touch Ultrasound Diagnostic ultrasound imaging or fluid flow analysis of the human body Recall Number Z-2217-2016 REASON A software issue related to the generic volume measurement...Read More
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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.