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Company: Merge Healthcare, Inc. Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1180-2017 REASON The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Recall Number Z-1176-2017 REASON Potential exists for an incorrect patient image being displayed which could result in the delay in diagnosis or treatment. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland,...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station Recall Number Z-1142-2017 REASON Merge received reports of Merge Eye Station...Read More

Company: Physio-Control, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. Recall Number Z-1144-2017 REASON The End-Tidal CO2 (EtCO2) reading can intermittently show a value...Read More

Company: Physio-Control, Inc. Date of Enforcement Report 2/15/2017 Class lI: PRODUCT LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of...Read More

Company: Boston Scientific Corporation Date of Enforcement Report 2/152017 Class lI: PRODUCT Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station Recall Number Z-1178-2017 REASON There is a potential for radio frequency...Read More