Company: Philips Medical Systems Date of Enforcement Report:12/195/2007 Class:ll PRODUCT Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Recall Z-0451-2008 REASON Alarm failure: If changes are made to the Care Group Editor configuration, Care Group alarm status,...Read More

Company: Accuray Inc, Date of Enforcement Report:12/19/2007 Class:ll PRODUCT Accuray, Multiplan Treatment Planning Software, Recall # Z-0364-2008 REASON Software problem – Sagittal, oblique or coronal sliced MR Images imported from a non-Accuray manufactured device into the product may result in inverted image orientation. RECALLING FIRM/MANUFACTURER Accuray Inc, Sunnyvale, CA, by Urgent Advisory Notification on March...Read More

Company:Abbott Laboratories, Inc Date of Enforcement Report:12/19/2007 Class:ll PRODUCT a) ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106- 01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10, Recall $ Z-0146-2008; b) ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20,...Read More