HIGH

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.

Quick Facts at a Glance

Recall Date
February 27, 2026
Hazard Level
HIGH
Brand
GE Healthcare
Geographic Scope
1 states

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Healthcare LLC or your healthcare provider for instructions

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Full Description

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.. Classification: Class II. Quantity: 41. 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

View Original Recall on FDA - Medical Devices

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Product Classification

Product Details

Model Numbers
UDI-DI/GTIN: 00840682135269
00195278010797. System ID: 415353UMR2
415723SHMR19
413253MR3T
908725MR
+15 more
Affected States
ALL
Report Date
April 8, 2026
Recall Status
ACTIVE

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