FDA DevicesClass II
SIGNA Premier systems
Published: April 8, 2026Recall ID: Z-1767-2026Category: devicesCountry: US
Reason for Recall / Hazard
Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Product Description & Identification
SIGNA Premier systems
Additional Source Details
| Field | Value |
|---|---|
| City | Florence |
| State | SC |
| Event id | 98579 |
| Address 1 | 3001 W Radio Dr |
| Code info | UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 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 |
| Postal code | 29501-7806 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 41 |
| Reason for recall | Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Center classification date | 20260402 |
Overview
- Recalling FirmGE Healthcare LLC
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of