Company:Philips Medical Systems
Date of Enforcement Report 2/20/2008
Class:ll
PRODUCT
Philips Medical Systems — Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5, Recall Z-0676-2008
REASON
Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file..
RECALLING FIRM/MANUFACTURER
Phillips Nuclear Medicine, Milpitas, CA, by letter on September 28, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide and Internationally
