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Open, Classified

SIGNA Premier systems

FDA Recall Z-1767-2026 · Posted 2026-04-02

Recalling FirmGE Healthcare LLC
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2026-02-27
Product Quantity41

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 ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.

Firm Action

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 [email protected] 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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