Philips Medical Systems Class II

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.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.