Company: Siemens Medical Solutions USA, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT a) MR Systems. Recall # Z-1087-03; b) Leonardo Workstations with software version 2022A/B, 2003A. Recall # Z-1088-03; c) Leonardo Workstations with software versions prior to 2022A. Recall # Z-1089-03. REASON Software problem. This error may cause the loss of peripheral image information...Read More

Company: Olympus America, IncDate of Enforcement Report: 8/27/03 Class: II PRODUCT Olympus Image Manager Software. Recall # Z-1126-03. REASON Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system. CODE Versions 6.0 through 6.4. RECALLING FIRM/MANUFACTURER Olympus America, Inc., Melville, NY, by letters, dated...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 8/27/03 Class: II PRODUCT Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access Results Workstation. Recall # Z-1093-03. REASON Software defect. When Quality Assurance failure warnings are missing from a patient’s report abnormal results could be used for diagnosis or treatment. CODE Versions 5.3 up to...Read More