Company:Philips Medical Systems
Date of Enforcement Report 1/11/12
Class ll:
PRODUCT
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data. Model Number 882488: EBW NM Special Model Number 882489: Extended Brilliance Workspace NM Model number 728260: Extended Brilliance Workspace. Recall # Z-0182-2012
REASON
A problem related to a software error has been detected. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, San Jose, CA, by letter on September 27, 2011.
Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,181 systems
DISTRIBUTION
Nationwide and Canada
