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GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging… recallZ-2302-2025 · GE Medical Systems, LLC · initiated Jun 20, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from GE Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Equipment maintenance

What the company is doing

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."

Recall details

Recall number
Z-2302-2025
Status
Open, Classified
Initiated by the company
Jun 20, 2025
Posted by the FDA
Aug 13, 2025
Recalling firm
GE Medical Systems, LLC
Quantity
1372 units
Product code
LNH
FDA submissions
K132376, K142085, K160618, K163331
Distribution
Worldwide distribution.

Product description

GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

Code information (models, lots, serial numbers)

00195278023643, 00195278117021, 00195278126443, 00195278210036, 00195278229519, 00840682115971, 00840682118118, 00840682118132, 00840682123129, 00840682123457, 00840682123457, 00840682146104, Not applicable, Not available; All System ID numbers that GE HealthCare performed planned maintenance on since March 1, 2023

Devices named in this recall

10 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

9 devices cleared under K132376, K142085, K160618, K163331 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97187).

Sources and updates

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