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September 7, 2016
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....
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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...
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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...
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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...
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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...
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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...
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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...
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http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM524904.pdf
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http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM519346.pdf
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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...
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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...
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