FDA · Medical device recall

GE Discovery MR950 MRI system

May 13, 2015 Class II

Date: May 13, 2015
Risk class: Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status: Terminated
Filed by: GE Healthcare
Product: GE Discovery MR950 MRI system
Reason: The alignment lasers are missing the labels required by radiation safety regulations.
Distribution pattern: US Distribution to the state of CA., and Internationally to Italy and Japan.
Quantity: 5 units (2 in US)
Codes and lots: Model Number - Discovery MR950
Recall started: Oct. 24, 2014
Device type: Monitor, Patient Position, Light-Beam
Root cause (FDA): Error in labeling
What the company told customers: 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.
Recall number: Z-1395-2015

Source: FDA · Medical device enforcement report, recall number Z-1395-2015. The agency record governs; check it and the company before acting.

Report a mistake on this page