Company: Philips Medical Systems
Date of Enforcement Report 9/3/2008
Class:ll
PRODUCT
General X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, Recall # Z-2160-2008
REASON
X-ray images may be stored in the wrong patient file or corrupted; images from two different patients may be combined in one patient’s folder or may be combined on one image (corrupted).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on May 20, 2008.
Manufacturer: Philips Medical System, The Netherlands. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide
