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...
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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...
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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)...
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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,...
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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....
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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...
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