GE Healthcare LLC recalls 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.

On 2/27/2026, correction notices were mailed to Director of Clinical/Radiology Risk Manager/Hospital Administrators informing them to take the following actions: 1) Ensure all potential servicing personnel in your facility are made aware of this safety notification and the recommended actions. 2) If the device requires service at the rear of the magnet, ensure that all servicing personnel are aware of this potential issue. 3) If servicing personnel have accessed the rear of the magnet with covers removed and identified that ferrous fittings are installed, do NOT attempt to remove or disconnect them. Call your GE HealthCare representative immediately. To help identify the parts: -The incorrect fittings (ferrous) are steel/silver in color -The correct fittings (non-ferrous) are brass/gold in color 4) Complete and return the acknowledgement form electronically via (https://gehealthcare-svc.my.site.com/publicForm/s/?formId=aGjUr000002kiJR) or print, fill out manually, scan and email to Recall.63006@gehealthcare.com If you have any questions or concerns regarding this notification, please contact the firm's HealthCare Service at 1-800-437-1171 or your local Service Representative.

• FDA enforcement recordOfficial FDA database entry for Z-1767-2026
• FDA 510(k) clearance · K171128The device's official FDA premarket clearance record
• FDA 510(k) clearance · K183231The device's official FDA premarket clearance record
• FDA 510(k) clearance · K193282The device's official FDA premarket clearance record
• FDA device classification · LNHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.1000The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find GE Healthcare LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.