Company: Merge Healthcare, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-2627-2016 REASON Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2652-2016 REASON After upgrading to 3.6.7 software...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2655-2016 REASON After upgrading to 3.6.7 software version...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Ingenuity Core Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2657-2016 REASON After upgrading to 3.6.7 software version...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2654-2016 REASON After upgrading to 3.6.7...Read More

Company: Baxter Healthcare Corp. Date of Enforcement Report 8/30/2016 Class lI: PRODUCT 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis...Read More

Company: Stryker Instruments Div. of Stryker Corporation Date of Enforcement Report 8/30/2016 Class lI: PRODUCT 120 V Neptune 3 Rover, Model Number: 0703-001-000 Recall Number Z-2630-2016 REASON Stryker initiated a voluntary recall of the 120 V Neptune 3 Rover on 07/01/2016, due to a potential for the device to experience system errors causing the device...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/24/2016 Class lI: PRODUCT iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. Recall Number Z-2531-2016 REASON Studies that are viewed in iConnect Access that originate on...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/24/2016 Class lI: PRODUCT iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks. Recall Number Z-2532-2016 REASON Studies that are viewed in iConnect Access that originate on...Read More

Company: Toshiba American Medical Systems Date of Enforcement Report 8/24/2016 Class lI: PRODUCT Xario 100 Diagnostic Ultrasound System, TUS-X100; Xario 200 Diagnostic Ultrasound System, TUS-X200. Recall Number Z-2542-2016 REASON Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error. RECALLING FIRM/MANUFACTURER Toshiba American...Read More

Company: Ge Healthcare ItDate of Enforcement Report 8/24/2016 Class lI: PRODUCT GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. Also used as a clinical review workstation throughout the...Read More

Company: AB Sciex Date of Enforcement Report 8/24/2016 Class lI: PRODUCT AB Sciex API 3200MD” LC/MS/MS System. In-Vitro Diagnostic Instrument Part Number (REF): 5024501 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating...Read More

Company: AB Sciex Date of Enforcement Report 8/24/2016 Class lI: PRODUCT AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031257 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/24/2016 Class lI: PRODUCT Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications , and media interchange of medical images from a variety of diagnostic imaging systems. Recall Number Z-2551-2016...Read More

Company: AB Sciex Date of Enforcement Report 8/24/2016 Class lI: PRODUCT AB SCIEX QTRAP 4500MD LC/MS/MS System Mass Spectrometer for In-Vitro Diagnostic Use. Instrument Part Number (REF): 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound...Read More

Company: Ortho-Clinical Diagnostics Date of Enforcement Report 8/24/2016 Class lI: PRODUCT ORTHO ProVue Analyzers; Product Code MTS213784; Unique Device Identifier (GTIN) 10758750006014 Recall Number B-0686-16 REASON ORTHO ProVue Analyzers, with suboptimal reference images and/or Brillo values outside of specification, were distributed. RECALLING FIRM/MANUFACTURER Ortho-Clinical Diagnostics, Rochester, NY on 6/14/2016. Voluntary: Firm Initiated recall is ongoing....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2366-2016 REASON Software defect causing intermittently slow response of Host. RECALLING FIRM/MANUFACTURER...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Stratus CS STAT Fluorometric Analyzer-microproc essor-controlled instrument that measures certain analytes in body fluids for in vitro diagnostic use. Assays include ~hCG, CRP, CKMB, cTNI, D-Dimer, Myoglobin, and pBNP. SMN: 10444834, 10453531 Recall Number Z-2525-2016 REASON Software defect, where either an Above...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. Recall Number Z-2382-2016 REASON Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. Recall Number Z-2380-2016 REASON Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips Medical Systems,...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance 16 Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2369-2016 REASON Software defect causing intermittently slow response of Host....Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848281, 10848282, 10848283, 10848353, 10848255 Artis zee / zeego and Q/ Q.zen is a family of dedicated angiography systems developed for single and...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. Recall Number Z-2346-2016 REASON The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used for...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2371-2016 REASON Software defect causing intermittently slow response of Host....Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Model No. 728323; To produce cross-sectional images of the body. Recall Number Z-2384-2016 REASON Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Cleveland, OH...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. Recall Number Z-2383-2016 REASON Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body. Recall Number Z-2381-2016 REASON Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment. RECALLING FIRM/MANUFACTURER Philips Medical...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance BigBore Oncology Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2367-2016 REASON Software defect causing intermittently slow response of Host. RECALLING...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. Recall Number Z-2347-2016 REASON The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: 1. During the filming operation on MX16-slice console software, the clipboard used...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Brilliance CT 16 Power Computed Tomography X-ray systems X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Recall Number Z-2370-2016 REASON Software defect causing intermittently slow response...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2363-2016 REASON When measuring a lesion on an...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/17/2016 Class lI: PRODUCT Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI. Recall Number Z-2379-2016 REASON The patient name in the Halo title bar and the thumbnails do not match the name on...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...Read More

Company: B-K Medical A/S. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT BK Medical ApS Ultrasound System Scanner bk2300 – Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge HEMO software Recall Number Z-2341-2016 REASON The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7 RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc. Hartland, WI on 7/2/2012 Voluntary:...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2303-2016 REASON A migrated...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 8/10/2016 Class lI: PRODUCT IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images. Recall Number Z-2301-2016 REASON Studies coming over via telmed were missing...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures....Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...Read More

Company: Medtronic Navigation, Inc. Date of Enforcement Report 8/10/2016 Class lI: PRODUCT S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous...Read More

Company: Ge Healthcare ItDate of Enforcement Report 8/3/2016 Class lI: PRODUCT Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing...Read More

Company: Elekta, Inc. Date of Enforcement Report 8/3/2016 Class lI: PRODUCT MOSAIQ Oncology Information System Recall Number Z-2293-2016 REASON It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order. RECALLING FIRM/MANUFACTURER Elekta, Inc., Atlanta,...Read More

Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 XPS High Speed Compounder REF 58810 Recall Number Z-2257-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device,...Read More

Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 XP High Speed Compounder REF 58810 Recall Number Z-2258-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device,...Read More

Company: The Metrix Company Date of Enforcement Report 8/3/2016 Class lI: PRODUCT AUTOCOMP6 High Speed Compounder Recall Number Z-2259-2016 REASON An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined...Read More

Adamson Analytical Laboratories, Inc.Product: finished pharmaceuticals Date: 8/2/2016 This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211, and significant deviations from CGMP for active pharmaceutical ingredients (API). Your firm failed to exercise appropriate controls over computer or related systems to assure that...Read More