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Urgent Enforcement Amended Final

GE Healthcare SIGNA Premier Whole-Body MR Scanner Recall - Class II

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Summary

FDA and GE Healthcare initiated Class II recall Z-1767-2026 for SIGNA Premier whole-body MR scanners. Affected devices may have been manufactured or serviced with ferrous (steel) fittings instead of required non-ferrous (brass) fittings on the magnet rear assembly. If serviced while the magnet is energized, incorrect fittings could pose safety risks. Recalls are distributed worldwide including 9 US states and multiple international markets. The recall is ongoing.

What changed

GE Healthcare issued a Class II medical device recall for SIGNA Premier whole-body MRI systems due to potential use of incorrect ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear assembly during manufacturing or servicing. \n\nHealthcare facilities and imaging centers using these systems should immediately verify whether their equipment is affected, avoid performing service access while the magnet is energized, and contact GE Healthcare for inspection and corrective fitting replacement. The recall affects systems distributed across US states (CA, MA, NJ, NY, OH, SD, TX, VA, PR) and internationally (Sweden, Switzerland, UK).

What to do next

  1. Identify any SIGNA Premier systems in your facility
  2. Contact GE Healthcare for inspection and replacement of fittings
  3. Do not access the system for service while magnet is energized until fittings are verified

Archived snapshot

Apr 14, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

GE Healthcare LLC

Device Recalls (Class II)

← All Device Recalls (Class II) Class II Z-1767-2026 · 20260408 · Ongoing

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 r...

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...

Source: openFDA Enforcement API

Named provisions

SIGNA Premier systems Magnet rear fittings

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Last updated

Classification

Agency
FDA
Filed
April 8th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Recall Z-1767-2026

Who this affects

Applies to
Medical device makers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical device recall response MRI system servicing Diagnostic imaging equipment
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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