Z-1395-2015Class II

GE Discovery MR950 MRI system

Name: Z-1395-2015 GE Discovery MR950 MRI system
Creator: GE Healthcare
Published: 2014-10-24
License: https://open.fda.gov/license/

GE Healthcare / initiated 2014-10-24 / Terminated / root cause: labeling and UDI

FDA source

GE Healthcare began a recall of GE Discovery MR950 MRI system on 2014-10-24. FDA classified it as Class II and gives the reason as "The alignment lasers are missing the labels required by radiation safety regulations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1395-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-24
Posted: 2015-05-01
Terminated: 2015-05-06
Recalling firm: GE Healthcare
Product: GE Discovery MR950 MRI system
Product code: IWE Monitor, Patient Position, Light-Beam
Reason for recall: The alignment lasers are missing the labels required by radiation safety regulations.
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Model Number - Discovery MR950

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1395-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1395-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01

Product code IWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)