Company:Smiths Medical MD, Inc., . Date of Enforcement Report:4/11/2007 Class:ll PRODUCT Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP); RX ONLY, Recall # Z-0718-2007 REASON The year of manufacture had been incorrectly entered as 1980 into the...Read More

Company:Radiometer America Inc. Date of Enforcement Report:4/11/2007 Class:ll PRODUCT ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27, Recall # Z-0705-2007 REASON In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific...Read More

Company:Pulse Biomedical, IncDate of Enforcement Report:4/11/2007 Class:ll PRODUCT QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine, Recall # Z-0716-2007 REASON No 510 (k) marketing clearance for the product. CODE Serial numbers: 4605AU0251E, 2306AU0600E-BT, 2306AU0601E-BT, 2406AU0610E-BT, and 2706AU0641E-BT. RECALLING FIRM/MANUFACTURER...Read More