Company: CHG Hospital Beds Inc. Date of Enforcement Report 3/23/2016 Class lI: PRODUCT The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable...Read More

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...Read More

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....Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

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...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips IntelliVue Measurement Module X1 Model: M3001A. Recall Number Z-0853-2016 REASON The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.. Recall Number Z-0862-2016 REASON Siemens is releasing...Read More

Company: Regulatory Insight, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. Recall Number Z-0753-2016 REASON It was discovered that the Remote Touch...Read More

Company: Regulatory Insight, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system. Recall Number Z-0803-2016 REASON The Firm has discovered a Software bug. RECALLING FIRM/MANUFACTURER Olympus Scientific Solutions Americas, Waltham,MA on 2/19/2016. Voluntary: Firm Initiated recall is...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm). Recall Number Z-0857-2016 REASON Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.. RECALLING FIRM/MANUFACTURER Philips Medical Systems,...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 3/2/2016 Class lI: PRODUCT software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/2/2016 Class lI: PRODUCT Philips Healthcare IntelliVue Info Center iX, A.0 866023 Recall Number Z-0856-2016 REASON Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Andover, MA on 2/23/2016. Voluntary:...Read More

Company: Varian Medical Systems, Inc. Date of Enforcement Report 2/24/2016 Class lI: PRODUCT Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external...Read More

Company: CareFusion 303, Inc. Date of Enforcement Report 2/24/2016 Class lI: PRODUCT An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations and dispensing medication for patients....Read More

Company: Bio-Rad Laboratories, Inc.Date of Enforcement Report 2/24/2016 Class lI: PRODUCT EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator’s Manual. In vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays. Recall Number Z-0807-2016 REASON The error...Read More

Company: Merge Healthcare Inc. Date of Enforcement Report 2/10/2016 Class lI: PRODUCT RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF390E, 5.30.5 SB0368, 5.30.6, 5.30.6 HF0405E, 5.30.6 HF0406E, 5.30.7, 5.30.7 HF0429E, 5.30.7 HF0441E, 5.30.7 HF0446E, 5.30.7 HF0470E, 5.30.7...Read More

Company: Toshiba American Medical Systems Inc. Date of Enforcement Report 2/17/2016 Class lI: PRODUCT INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems Recall Number Z-0752-2016 REASON When a fontal DA (Digital Angiography) acquisition was done, scattered x-ray came into the dose meter on the lateral side. As a result, the dose meter sent a minus value...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 kg.)...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/102016 Class lI: PRODUCT Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). Recall Number Z-0702-2016...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). Recall Number Z-0703-2016 REASON The use of Allura Xper, Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including diagnostics, interventional...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including diagnostics, interventional...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: ” Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. ” Cardiac imaging applications including diagnostics, interventional...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BH5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS Allura...Read More

Company: Radiometer America IncDate of Enforcement Report 2/10/2016 Class lI: PRODUCT AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. Recall Number Z-0748-2016 REASON The AQURE System has a design error regarding sample type in which sample type may be specified for some results and left blank for other results....Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional procedures. The Philips INTEGRIS...Read More

Company: Philips Electronics North America CorporationDate of Enforcement Report 2/10/2016 Class lI: PRODUCT UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: ” Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography,...Read More

Company: Mindray DS USA, Inc. dba Mindray North AmericaDate of Enforcement Report 2/10/2016 Class lI: PRODUCT Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in the healthcare facility setting...Read More

Company: Philips Medical Systems Date of Enforcement Report 2/10/2016 Class lI: PRODUCT DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621 Recall Number Z-0745-2016 REASON In DS/US proton planning, there is a correction factor used internally to the dose engine that is calculating improperly in some cases. This...Read More