Class 2 Device Recall GE Discovery MR950

• Date Initiated by Firm: October 24, 2014
• Date Posted: May 01, 2015
• Recall Status: Terminated on May 06, 2015
• Recall Number: Z-1395-2015
• Recall Event ID: 70701
• Product Classification: Monitor, patient position, light-beam - Product Code IWE
• Product: GE Discovery MR950 MRI system
• Code Information: Model Number - Discovery MR950
• Recalling Firm/ Manufacturer: GE Healthcare; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: 262-513-4122
• Manufacturer Reason for Recall: The alignment lasers are missing the labels required by radiation safety regulations.
• FDA Determined Cause: Error in labeling
• Action: GE Planned action(s) to repair defect or to bring product into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 5 units consists of the following: 1. New labels will be mailed to all purchasers, with instructions to apply the label in the appropriate location on the unit, or a GE field engineer will be sent to each user site to complete the correction. 2. All mailings and service calls will be made at no cost to the purchaser. 3. The corrections will be completed by August 1, 2015. If you have any questions, please contact your local Service Representative or call 1 (800) 437-1171.
• Quantity in Commerce: 5 units (2 in US)
• Distribution: US Distribution to the state of CA., and Internationally to Italy and Japan.
• 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.