Day

February 12, 2014
Company: Stryker Medical Division of Stryker Corporation Date of Enforcement Report:2/122014 Class lI: PRODUCT The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series...
Read More
Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report:2/12/2014 Class lI: PRODUCT Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.Recall Number Z-0907-2014 REASON During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version...
Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report:2/122014 Class lI: PRODUCT Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476) Recall Number Z-0932-2014 REASON The PET Reconstruction Server (PRS)...
Read More
Company: AGFA. Corp. Date of Enforcement Report:2/12/2014 Class lI: PRODUCT IMPAX RIS QDOC 5.8 Recall Number Z-0919-2014 REASON Patient name displayed (printed) on the Patient Report was the wrong patient name. RECALLING FIRM/MANUFACTURER AGFA. Corp., Greenville, SC. on 1/8/2014. Voluntary: Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 14 DISTRIBUTION CA, FL, GA,...
Read More
Company: GE Healthcare LLC Date of Enforcement Report: 2/12/2014 Class lI: PRODUCT CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time....
Read More
Company: B. Braun Medical, Inc.Date of Enforcement Report:2/122014 Class lI: PRODUCT B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications. Recall Number Z-0921-2014 REASON Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion...
Read More

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.