GE Healthcare SIGNA Premier Whole-Body MR Scanner Recall - Class II
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
- Identify any SIGNA Premier systems in your facility
- Contact GE Healthcare for inspection and replacement of fittings
- Do not access the system for service while magnet is energized until fittings are verified
Archived snapshot
Apr 14, 2026GovPing 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
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