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: 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: 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 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 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: 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: 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 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 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: 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