Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/31/2018 Class lI: PRODUCT Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. It supports the physician in diagnosis and treatment planning. Recall...Read More

Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device Recall Number Z-0400-2018 REASON Patients monitored on two (2) or...Read More

Company:Medtronic Inc., Cardiac Rhythm and Heart FailureDate of Enforcement Report 1/31/2018 Class lI: PRODUCT MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT SP – Model 728311 Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0402-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give...Read More

Company:Philips Medical Systems (Cleveland) IncDate of Enforcement Report 1/31/2018 Class lI: PRODUCT Brilliance iCT – Model 728306 Computed Tomography X-ray systems Recall Number Z-0403-2018 REASON Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image...Read More