GE Healthcare SIGNA Premier MRI scanners recalled for steel fittings hazard
GE Healthcare SIGNA Premier whole-body MRI scanners may have steel fittings instead of brass fittings on the magnet rear. During service work while the magnet is powered up, the magnetic field could pull on these steel parts, risking injury to technicians.
From the FDA notice · Read the official notice ↗ · All GE Healthcare recalls
What to do
- If you operate or service a SIGNA Premier scanner, contact GE Healthcare immediately for inspection and correction
- Do not allow service access to the magnet rear while the system is ramped (powered) until fittings are verified
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- SIGNA Premier systems
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 41
- Illnesses reported
- None reported
- Manufactured in
- 3001 W Radio Dr, Florence, SC, United States
- Classification
- Class II
- Recall number
- Z-1767-2026
In the FDA's words
- Description
- SIGNA Premier systems 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. 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 Distribution: Worldwide - 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 Affected quantity: 41
- 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.