Class 2 Device Recall

• Date Initiated by Firm: May 02, 2002
• Date Posted: September 12, 2003
• Recall Status: Terminated on April 11, 2005
• Recall Number: Z-1201-03
• Recall Event ID: 26579
• Product Classification: System, Nuclear Magnetic Resonance Imaging - Product Code LNH
• Product: Gyroscan 1.5T Intera
• 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: 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.