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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 November 21, 2002
Date Posted September 12, 2003
Recall Status1 Terminated 3 on January 13, 2005
Recall Number Z-1228-03
Recall Event ID 26580
510(K)Number K932645  
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Gyroscan NT-Intera
Code Information Serial numbers listed under Gyroscan ACS-NT with software versions R6x, R7x, R8x
Recalling Firm/
Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
Manufacturer Reason
for Recall
Patient burns from cables near or in contact with the patient during use
FDA Determined
Cause 2
Action On 11/21/02, the firm provided Field Change Order (FCO) 781 00006 to their field employees. This FCO instructed the field employees to visit the consignees and provide them with the addendums to the Instruction For Use Manual.
Distribution The firm distributed units to hospitals and medical centers throughout the U.S.
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.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.