• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  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/
Philips Medical Systems
22100 Bothell Everett Highway
Bothell WA 98041
For Additional Information Contact
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
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.