Company: Philips Medical Systems
Date of Enforcement Report: 7/31/02
Class: II
PRODUCT
Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging. Recall # Z-1147-2/Z-1148-2.
REASON
Higher than expected current in the insulation of the coil cable.
CODE
Software version R7.1.2 and higher
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.
