07

Aug

2002

Philips Medical Systems Class II

0

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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