Company: Merge Healthcare, Inc. Date of Enforcement Report 3/15/2017 Class lI: PRODUCT Merge Cardio software using EchoIMS Recall Number Z-1415-2017 REASON A situation can occur allowing two physicians to access the same study report in EchoIMS when launched from the Cardio Study List without receiving the read-only notification prompt. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland,...Read More

Company:Physio-Control, Inc. Date of Enforcement Report 3/15/2017 Class l PRODUCT The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. Recall Number Z-1257-2017 REASON The firm has received complaints that the LIFEPAK 1000 Defibrillator is...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 3/15/2017 Class lI: PRODUCT Merge Cardio software Recall Number Z-1403-2017 REASON When taking measurements from images on the Cardio workstation or from the US cart, numbers are not crossing to the report in the correct unit of measure. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 4/4/2016....Read More