Company: Philips Medical Systems Date of Enforcement Report 1/2/2008 Class:ll PRODUCT a) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini TFs, GXLs and EBW Workstations. (The product is a software application that is installed in Philips Medical System CT scanners.), Recall # Z-0366-2008; b) Philips Medical Systems, Cardiac...Read More

Company: Ellex, Inc., Date of Enforcement Report 1/2/2008 Class:ll PRODUCT Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Recall # Z-0148-2008 REASON Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations....Read More

Company:Beckman Coulter Inc Date of Enforcement Report 1/2/2008 Class:ll PRODUCT a) COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer, Recall # Z-0312-2008; b) COULTER LH780 Analyzer, Part Number: 723585, Hematology analyzer, Recall # Z-0313-2008; c) COULTER LH 500 Series System, Part Number: 178833, Hematology analyzer, Recall # Z-0314-2008; d) COULTER GEN*S System, Part Number: 6605381,...Read More