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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

GE Healthcare SIGNA Premier MR Scanners Recalled for Risk of Projectile Injury

Agency Publication Date: April 2, 2026
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Summary

GE Healthcare LLC is recalling 41 SIGNA Premier MR scanning systems because they may have been manufactured or serviced with steel (ferrous) fittings instead of the required brass (non-ferrous) fittings. These whole-body scanners are used to create images for medical diagnoses, but if steel fittings are present, the machine's powerful magnetic field could pull them toward the magnet with great force during service. No incidents or injuries have been reported to date, and the manufacturer is initiating this voluntary correction to replace the improper parts.

Risk

The magnetic field of the scanner can attract steel fittings, turning them into projectiles that could strike and injure service personnel or anyone near the magnet while it is powered on.

What You Should Do

  1. Identify if your SIGNA Premier system is affected by checking the System ID or UDI-DI/GTIN codes. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled device for any service procedures that require accessing the magnet rear while it is ramped (powered on).
  3. Contact GE Healthcare LLC or your local distributor to arrange for a service correction and replacement of any ferrous fittings with non-ferrous parts.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device for service activities involving the magnet rear. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SIGNA Premier systems
Model / REF:
415353UMR2
415723SHMR19
413253MR3T
908725MR
609652MR3T
M48823
7168453T
513584MR5
513636EASTMR
513636T1MR
605333MRPRM
832522CRMR1
703858PRE2
804675VA3T
082427110162
082427220143
082427020147
082427200242
082427160461
082427250139
082427140382
M4216469
353745MR01
GON5655515
KRMR56474971
KRMR56203791
KRMR55433661
KRMR56344161
KRMR55774051
KRMR55914661
NOMRI26833321
15974045
GON1882380
ESMRI27056983
ESMRI26960129
A203MR06
690120MR01
11524261
VNMRI26792525
VNMRI26592248
VNMRI26809677
UDI:
00840682135269
00195278010797
GTIN:
00840682135269
00195278010797

Quantity: 41 units affected. These are Whole-Body MR scanners.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98579
Status: Active
Manufacturer: GE Healthcare LLC
Sold By: GE Healthcare LLC
Manufactured In: United States
Units Affected: 41
Distributed To: California, Massachusetts, New Jersey, New York, Ohio, South Dakota, Texas, Virginia, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.