SIGNA Premier systems
FDA device recall Z-1767-2026 · posted 2026-04-02 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare LLC
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LNH
- Quantity affected
- 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, Ge
- Date initiated
- 2026-02-27
- Date posted
- 2026-04-02
- Location
- Florence, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNA Premier (K193282) | Ge Healthcare (Ge Medical Systems, LLC) | 2020-04-10 |
| SIGNA Premier (K183231) | Ge Medical Systems, LLC | 2019-01-18 |
| SIGNA Premier (K171128) | Ge Medical Systems, LLC | 2017-07-14 |