Company: Philips Medical Systems North America Co
Date of Enforcement Report: 7/6/05
Class: II
PRODUCT
View Forum 2003 software, SW 3.4L1, Recall # Z-0896-05
REASON
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
CODE
The firm utilizes site numbers: 534544, 520177, 520633, 532261, 504927, 532134, 534573, 531862, 521928, 522027, 521424, 533804, 532053
RECALLING FIRM
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 29, 2005.
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13 devices
DISTRIBUTION
Nationwide