Recall Z-1767-2026— GE Healthcare LLC

Name: FDA recall Z-1767-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-27

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare LLC, initiated 2026-02-27. It names 3 FDA 510(k) clearances: K193282, K183231, K171128. Product: SIGNA Premier systems. Reason: 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..

Recalling firm: GE Healthcare LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-02-27
Firm location: Florence, SC, United States

510(k) clearances named in this recall

3 on FDA's record

K193282 — SIGNA PremierGe Healthcare (Ge Medical Systems, LLC)·cleared 2020-04-10
K183231 — SIGNA PremierGe Medical Systems, LLC·cleared 2019-01-18
K171128 — SIGNA PremierGe Medical Systems, LLC·cleared 2017-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.