Company:Fujifilm Medical System USA, Inc.Date of Enforcement Report: 6/25/03 Class: II PRODUCT Synapse. Recall # Z-0932-03. REASON Synapse Version 2.2.1 and 2.3.1software (Free-Hand Region) may lead to incorrect density calculations during CT scan. CODE Version 2.2.1 and 2.3.1. RECALLING FIRM/MANUFACTURER Fujifilm Medical System USA, Inc., Stamford, CT, by letter during the week of May 12,...Read More

Company:Canon USA, Inc.Date of Enforcement Report: 6/25/03 Class: II PRODUCT Rational Imaging TM Software, model Ultra 10 PACS System. Recall # Z-0905-03. CODE RIUpdate 7.1.OK. RECALLING FIRM/MANUFACTURER Canon USA, Inc., Irvine, CA, by letters on March 11, and March 26, 2003. Firm initiated recall is ongoing. REASON Imaging archive system software mismatches images and patient...Read More