FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
- Recall number
- Z-2306-2025
- Recalling firm
- GE Medical Systems, LLC
- Product
- GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
- Status
- Open, Classified
- Initiated
- 2025-06-20
- Posted
- 2025-08-13
- Terminated
- not on file
- Reason
- GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, SIGNA Artist Evo, SIGNA Voyager AIR (China Only), SIGNA Architect AIR (China Only), SIGNA Premier XT (China Only), SIGNA Premier Elite (China Only), SIGNA Premier MAX (China Only), SIGNA Hero XT (China Only), SIGNA Hero Elite (China Only), SIGNA Hero MAX (China Only), SIGNA PET/MR AIR (China Only), SIGNA PET/MR AIR Plus (China Only), the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
- Root cause
- Equipment maintenance
- Action
- GE HealthCare issued an URGENT CORRECTION NOTICE to it consignees on 06/20/2025 via traceable means. The notice explained the safety issue and requested the following actions be taken: "You can continue to use your MR system by following the instructions below: In the undocked position, lock the table by pressing the pedal in the front of the table. Check to see that all casters are locked and that the table is secure. Contact your GE HealthCare representative for assistance if any of the casters do not lock. Before each patient transfer verify that the caster locks are engaged. If you notice more than one caster is damaged or fails to lock properly, use particular caution as the table may move while in use. No additional steps are required to continue to use your table in the docked position. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions." "GE HealthCare will inspect and if necessary, correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction." " if you have any questions for concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative."
- Quantity
- 330 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- GTIN: 00195278229519, 00840682115872, 00840682115971, 00840682118187, 00840682123129, 00840682146999, Not applicable, Not available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023
- 510(k) numbers
- ["K142085","K160618","K163331"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2183553
- 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