Company: Respironics California IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT Esprit Ventilator, Model V1000 Continuous Ventilator with Respiratory Mechanics. Recall # Z-0903-04. CODE All codes. RECALLING FIRM/MANUFACTURER Respironics California Inc., Carlsbad, CA, by technician visit on or about June 1, 2001. Firm initiated recall is complete. REASON Ventilator would spontaneously suspend ventilatory support to...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/19/04 Class: II PRODUCT Coulter LH750 Hematology Analyzer. Part Number 6605632. Recall # Z-0905-04. REASON If a customer enters a dilution factor for Sample B prior to the results from Sample A being transferred to the workstation, the predilute multiplication factor will be applied erroneously to the Sample...Read More

Company: Beckman Coulter, IncDate of Enforcement Report: 5/19/04 Class: II PRODUCT UniCel Dxl 800 Access Immunoassay System, P/N 973100. Recall # Z-0904-04. REASON Software coding error may cause a fatal error message. CODE All software versions prior to version 1.4. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letters on March 29, 2004. Firm initiated...Read More

Company: Baxter Healthcare Renal DivDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Baxter Renal Software Suite (Renal Link and PD Link). Recall # Z-0901-04; b) Renalsoft software system. Recall # Z-0902-04. REASON There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to...Read More

Company: ADAC Laboratories, MadisonDate of Enforcement Report: 5/19/04 Class: II PRODUCT a) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-9052A-ENG. Recall # Z-0911-04; b) Pinnacle3 Radiation Therapy Planning System, Model Number 9200-0613C-ENG. Recall # Z-0912-04; c) Pinnacle3 Radiation Therapy Planning System, Part Number 9104-2011A Rev. A. Recall # Z-0913-04; d) Pinnacle3 Radiation Therapy Planning System,...Read More