Company: Philips Medical Systems.Date of Enforcement Report: 9/17/03 Class: II PRODUCT Easy Access PACS System with software. Recall # Z-471-3. REASON Potential display of an incorrect body part description on patient images. CODE Software Release 5, 6.2, or 7.2. RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA, by letter on February 13, 2002. Firm initiated recall...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Misys Laboratory System. Recall # Z-1217-03. REASON Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported. CODE Version 5.2 through 5.3.2 using LabAccess Results. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ, by fax on...Read More

Company: Misys Healthcare SystemsDate of Enforcement Report: 9/17/03 Class: II PRODUCT Calculator/Data Processing Module for Clinical Use. Recall # Z-1220-03. REASON Software Design Defect. Under certain conditions, results are removed. CODE Version 3.x. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ by facsimile on July 24, 2003. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

/Docs/BloodBankingComputerValidationguidelines-ISBT-1202.pdfRead More

Company: Harvard Clinical TechnologyDate of Enforcement Report: 9/17/03 Class: II PRODUCT Harvard 2, Dual Infusion Pump (P/N 2002-001). Recall # Z-1208-03. REASON Under specific sequence conditions, the unit may appear to be infusing, but is not. CODE Software versions V1.2R or earlier. RECALLING FIRM/MANUFACTURER Harvard Clinical Technology, South Natick, MA, by letter on August 11,...Read More

While FDA regulates Blood Establishment Computer Systems (BECS) as medical devices as well as regulating the blood establishments themselves, many other countries take a different approach. According to the Danish Competent Authorities the European Union (EU) approach is that equipment for blood banks including transfusion and information systems with clinical data about the donors, blood...Read More