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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 02, 2002
Date Posted September 12, 2003
Recall Status1 Terminated 3 on April 11, 2005
Recall Number Z-1200-03
Recall Event ID 26579
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Gyroscan NT-Intera 1.5T
Code Information Serial numbers provided above
Recalling Firm/
Manufacturer		 Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
425-487-7000
Manufacturer Reason
for Recall		 Patient burns related to high SAR levels and the combined use of Synergy Body Coil and synergy Flex-M coil
FDA Determined
Cause 2		 Other
Action The firm issued a Field Change Order to their field personnel instructing them to add new labeling to the User Manual. 05/02/2002 A letter was issued to customers.
Quantity in Commerce see above
Distribution The firm distributed units to hospitals and medical centers nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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