Company: Philips Medical Systems, Inc. Date of Enforcement Report 3/11/2015 Class lI: PRODUCT Philips Medical System Allura Xper X-Ray Angiographic Recall Number Z-1120-2015 REASON In certain circumstances, a software error can lead to a situation where the five minute fluoroscopy audible signal does not sound. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Inc., Andover, MA 6/6/2014. Voluntary:...Read More

Company: Medtronic MiniMed Inc. Date of Enforcement Report 3/11/2015 Class lII: PRODUCT CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management...Read More

Company:INO Therapeutics (dba Ikaria).Date of Enforcement Report: 3/11/2015 Class lI: PRODUCT Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators. Recall Number Z-1223-2015 REASON Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm...Read More