Company: Merge Healthcare, Inc. Date of Enforcement Report 9/14/2016 Class lI: PRODUCT Merge RadSuite software. Radiological image processing system. Recall Number Z-2715-2016 REASON When RadSuite is used with IPID (Issuer of Patient ID) as a part of the “Patient Identifier,” it is possible in some circumstances that the demographics of one patient will be applied...Read More

National Law Review discusses a case before the EU Court of Justice to decide if medical software that provides support to healthcare professionals in prescribing medicinal products should be considered a medical device. The manufacturer prefers it to be considered a medical device to avoid more onerous requirements if it is not treated that way.Read More

/docs/scpred/SoftwareCPR-NewsletterSept2016.pdfRead More

http://www.fda.gov/Training/CDRHLearn/default.htmRead More

Company: Elekta, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment. Recall Number Z-2691-2016 REASON Potentially unrecognized incorrect position of the treatment couch in 3D...Read More

Company: GE Healthcare ItDate of Enforcement Report 9/7/2016 Class lI: PRODUCT Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/7/2016 Class lI: PRODUCT Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. Recall Number Z-2709-2016 REASON A report can be confirmed with the incorrect patient demographics resulting in it being saved under the incorrect patient record in the...Read More

Company: Bio-Rad Laboratories, Inc. Date of Enforcement Report 9/7/2016 Class lII: PRODUCT TANGO Infinity, catalog # 850000010, Software version 1.2 Recall Number B-0746-16 REASON TANGO Infinity System, with a defect or glitch allowing an incorrect microplate type, was distributed. RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories, Inc. , Redmond, WA on 9/1/2016. Voluntary: Firm Initiated recall is ongoing....Read More

http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdfRead More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/7/2016 Class lI: PRODUCT RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. Recall Number Z-2685-2016 REASON Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/7/2016 Class lI: PRODUCT iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data. Recall Number Z-2686-2016 REASON Interventional Radiology (IR) images...Read More

Company: Nidek Inc Date of Enforcement Report 9/7/2016 Class lI: PRODUCT SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/7/2016 Class lI: PRODUCT ADVIA Chemistry XPT, SMN 10723034, IVD. — This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry XPT System is an...Read More

Company: Elekta, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-2712-2016 REASON In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved...Read More

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdfRead 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: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/31/2016 Class lI: PRODUCT SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system. Recall Number Z-2625-2016 REASON Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the...Read More

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 Ingenuity Core128 Model number 728323 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-2658-2016 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 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: Merge Healthcare, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a...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: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/31/2016 Class lI: PRODUCT SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system. Recall Number Z-2624-2016 REASON Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the...Read More

Company: INNOKAS MEDICAL OY Date of Enforcement Report 8/31/2016 Class lI: PRODUCT CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient’s vital signs at the site of care. Recall Number Z-2604-2016 REASON A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements. RECALLING FIRM/MANUFACTURER INNOKAS...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 8/31/2016 Class lI: PRODUCT Brilliance CT 16 Power, Model number 728240 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-2656-2016 REASON After upgrading to 3.6.7...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 8/31/2016 Class lI: PRODUCT SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system Recall Number Z-2626-2016 REASON Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the...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 Brilliance CT Big Bore Oncology, Model number 728243 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-2653-2016 REASON After upgrading to...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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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 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 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: 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 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 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: 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 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: 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 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 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