Company:Kimberly-Clark Corporation Date of Enforcement Report 12/5/12 Class ll: PRODUCT Kimberly-Clark Patient Warming System – Model 1000 Control Unit The product is a thermal regulating system, indicated for monitoring and controlling patient temperature. Recall Number Z-0451-2013 REASON Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately RECALLING FIRM/MANUFACTURER Kimberly-Clark Corporation, Roswell,...Read More

Company:GE Healthcare LLC Date of Enforcement Report 12/5/12 Class ll: PRODUCT GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is...Read More