Day

March 16, 2016
Company: Spacelab Healthcare, Inc. Date of Enforcement Report 3/16/2016 Class lI: PRODUCT Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. Recall Number Z-1092-2016 REASON The firm has received one report of values...
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Company: Philips Respironics. Date of Enforcement Report 3/46/2016 Class lI: PRODUCT Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.. Recall Number Z-1065-2016 REASON Software issue. RECALLING FIRM/MANUFACTURER Philips...
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Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/16/2016 Class lI: PRODUCT Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. The VITROS 5.1, FS Chemistry System performs discrete clinical tests on serum, urine, and...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using...
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens....
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Company: Ortho-Clinical Diagnostics Date of Enforcement Report 3/16/2016 Class lI: PRODUCT VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral...
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/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdf
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/docs/scpred/FDA-2015WL-483DataPresentationV_1312016.pdf
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