Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Axiom Sensis. Programmable Diagnostic Computer. Recall # Z-0979-03. REASON Software problem – erroneous results or system crashes. CODE Part numbers 6623974 and 6634633. Serial numbers 06011, 06012, 06018, and 02016. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc., Malvern, PA, by letter in...Read More

Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Axiom Aristos X-Ray System. Recall # Z-0984-03. REASON Software malfunction. May indicate that the image is flipped when it is not. CODE Part numbers 5895003 and 7414803. Serial numbers 01001, 01170, 01219, 01221, and 01030. RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc.,...Read More

Company: Siemans Medical Solutions USA, IncDate of Enforcement Report: 7/23/03 Class: II PRODUCT Acuson Cypress Echocardiography System, Imaging System. Catalog # 8264604. Recall # Z-0975-03. REASON Software problem – loss of data. CODE Serial numbers 70000 through 72000. RECALLING FIRM/MANUFACTURER Siemans Medical Solutions USA, Inc., Plymouth Meeting, PA, by letter dated April, 2003. Firm initiated...Read More

Company: Deltec, Inc.Date of Enforcement Report: 7/23/03 Class: II PRODUCT Deltec CASS-Prizm PCS II Ambulatory Infusion Pump with Revision E Software. Recall # Z-0980-03. REASON Pump keyboard entries by the patient can result in the patient having unintended access to programming screens and result in improper drug dosage. CODE Pump Serial numbers 658825, 658837, 658840,...Read More