notyard
09-04-2008, 10:42 AM
FDA class II recall:
PRODUCT
General X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, Recall # Z-2160-2008
CODE
Serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164
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.
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).
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide
PRODUCT
General X-Ray System types with Digital Spot Imaging (DSI) software. Software version: rel 6, Recall # Z-2160-2008
CODE
Serial numbers: 8, 18, 31, 40, 41, 45, 51, 52, 62, 63, 67, 71, 78, 79, 83, 84, 87, 88, 99, 100, 102, 104, 105, 106, 112, 116, 117, 118, 119, 127, 131, 132, 134, 136, 143, 146, 149, 153, 157, 163, and 164
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.
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).
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide