Recalls / —

—#134519

Product

GE Discovery MR950 MRI system

FDA product code

IWE — Monitor, Patient Position, Light-Beam

Device class

Class 1

Medical specialty

Radiology

Affected lot / code info

Model Number - Discovery MR950

Why it was recalled

The alignment lasers are missing the labels required by radiation safety regulations.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm

GE Healthcare

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern

US Distribution to the state of CA., and Internationally to Italy and Japan.

Timeline

Recall initiated

2014-10-24

Posted by FDA

2015-05-01

Terminated

2015-05-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #134519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.