Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 5/28/03 Class: II PRODUCT a) Leonardo MM-WS systems. System, Image Processing. Recall # Z-0841-03; b) Smatom Sensation 16, Computed Tomography System, Diagnostic Imaging. Recall # Z-0842-03. REASON Perfusion CT is displaying a higher gray and color values than normal. A software problem. CODE a) Model Number...Read More

Company: Philips Medical Systems (Cleveland) IncDate of Enforcement Report: 5/28/03 Class: III PRODUCT a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Recall # Z-0835-03. b) Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. Recall # Z-0836-03. REASON Patient images may be stored in the archive directory of a different patient. CODE a)...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 5/28/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-0804-03. REASON Software anomaly may result in incorrect values and interpretations. CODE Versions 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on March 27, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE...Read More

Company: Misys Healthcare SystemDate of Enforcement Report: 5/28/03 Class: III PRODUCT Misys Commercial Laboratory, Laboratory Information System. Recall # Z-806-03. REASON Software logic error. Dates were printing incorrectly on cumulative reports. CODE Version 3.4.1. RECALLING FIRM/MANUFACTURER Misys Healthcare System, Plano, TX, by letter on March 13, 2003. Firm initiated recall is complete. VOLUME OF PRODUCT...Read More

Company: Deltec, Inc.Date of Enforcement Report: 5/28/03 Class: II PRODUCT Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior. Recall # Z-0798-03. REASON A software error can result in the delivery of a larger bolus of insulin than anticipated when...Read More

Company: Beckman Coulter, Inc.Date of Enforcement Report: 5/28/03 Class: III PRODUCT COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03. REASON Software problem may cause the instrument to skip the probe-wash step before processing different reagents. CODE All existing versions of the software. Serial numbers PrepPlus 0006026440 and above...Read More

Company: Abbott Laboratories, IncDate of Enforcement Report: 5/28/03 Class: II PRODUCT a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version. Recall # Z-0792-03; b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9 Software Version. Recall # Z-0793-03; c) Gemstar_ Therapy Pain Management I.V. Infusion Pump, List#: 13150-04; 2.9 Software Version. Recall...Read More