GE Discovery MR950 MRI system

FDA device recall Z-1395-2015 · posted 2015-05-01 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

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

Action taken

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.

Root cause

Error in labeling

Status

Terminated

Product code

IWE

Quantity affected

5 units (2 in US)

Distribution

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

Date initiated

2014-10-24

Date posted

2015-05-01

Date terminated

2015-05-06

Location

Waukesha, WI