Company:Philips Healthcare IncDate of Enforcement Report 1/27/2010 Class:ll PRODUCT 1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4″display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4″ display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4″...Read More

Company:Hocoma AG,br>Date of Enforcement Report 1/27/2010 Class:ll PRODUCT Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. Recall # Z-0590-2010 REASON Changes to the stored “sensitivity” values may occur and leads to higher limits in...Read More