FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Discovery MR950 MRI system
- Recall number
- Z-1395-2015
- Recalling firm
- GE Healthcare
- Product
- GE Discovery MR950 MRI system
- Status
- Terminated
- Initiated
- 2014-10-24
- Posted
- 2015-05-01
- Terminated
- 2015-05-06
- Reason
- The alignment lasers are missing the labels required by radiation safety regulations.
- 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
- 5 units (2 in US)
- Distribution
- US Distribution to the state of CA., and Internationally to Italy and Japan.
- Lot, serial or model codes
- Model Number - Discovery MR950
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IWE
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28