Company: Philips Medical Systems
Date of Enforcement Report: 8/7/02
Class: II
PRODUCT
1.5T MR Systems with software version R7.1.2 and higher:
Magnetic Resonance Systems are indicated for use as diagnostic devices that produce transverse, sagital, coronal and oblique cross-sectional images, spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that display the internal structure and/or function of the head, body or extremeties. These images and/or spectra, when interpreted by a trained physician, yeild information that may assist in diagnosis. The coils are used to obtain optimal imaging. Recall # Z-1147-2.
REASON
Higher than expected current in the insulation of the coil cable.
CODE
Release 6.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated October 26, 2001.
Manufacturer: Philips Medical Systems, Nederland B.V. Netherlands. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
3.
DISTRIBUTION
FL and WA.
