GE Healthcare LLC voluntarily recalled 41 SIGNA Premier whole-body MR scanners on Feb. 27, 2026, after the FDA announced the devices may contain ferrous fittings that could attract to the magnet and injure personnel. The Food and Drug Administration issued the Class II recall.
How to tell if you have it
- SIGNA Premier systems
- UPC 00195278010797
- UPC 00840682135269
- System IDs: 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
The hazard
The scanners may have been manufactured or serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear. If the system is accessed for service while the magnet is ramped, the magnetic field could attract these fittings, potentially resulting in personnel injury.
Context
GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since Oct. 4, 2017. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanner Recall (June 24, 2022) and GE Centricity Universal Viewer 6.0/7.0/8.0 (July 15, 2022). I.T.S. Hand Locking Plates System (Jan. 23, 2026), I.T.S. Screw System (Jan. 23, 2026), and I.T.S. GmbH Pelvic Reconstruction System (Jan. 23, 2026) were also recalled for MRI safety risks.