FDA recall record

GE Healthcare SIGNA Premier systems recall — FDA Z-1767-2026

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…

Class IIclassification
Z-1767-2026official record ID
Apr 8, 2026report date

Recall record at a glance

Official recordZ-1767-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmGE Healthcare LLC
Report dateApr 8, 2026
Recall initiation dateFeb 27, 2026
Quantity41
LocationFlorence, SC, United States

Official product description

SIGNA Premier systems

Why the product was recalled

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 information

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

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: not stated.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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