FDA-Device2026-04-08Class IIPROCESSING DEFECT

GE Healthcare SIGNA Premier MRI scanners recalled for steel fittings hazard

Nationwide distributionMedical devices

What this means

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.

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

The agency's original wording

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

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 count

Manufactured in

3001 W Radio Dr, Florence, SC, United States

Products

SIGNA Premier systems

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1767-2026

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