Company: Philips Medical SystemsDate of Enforcement Report: 1/12/05 Class: II PRODUCT Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05. REASON In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy. CODE...Read More

Company: Dade Behring, IncDate of Enforcement Report: 1/12/05 Class: II PRODUCT StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05. REASON Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems. CODE Software version 3.5. RECALLING FIRM/MANUFACTURER Dade Behring, Inc., Newark, DE, by letters dated November 12,...Read More

Company: Baxter Healthcare Corp.Date of Enforcement Report: 1/12/05 Class: II PRODUCT a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R; Made in Singapore; monochrome display screen. Recall # Z-0342-05; b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Made in Singapore; monochrome display screen. Recall # Z-0343-05; c)...Read More