FDA recall Z-1767-2026

GE Healthcare LLC · Class II · device

Product

SIGNA Premier systems

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.

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

Key facts

Status
Ongoing
Initiation date
2026-02-27
Report date
2026-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Florence, SC, United States

Primary source

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