FDA recall, , Moderate risk
GE Healthcare SIGNA Premier Systems
SIGNA Premier systems, whole-body MR scanners, may have ferrous fittings that could attract and cause injury during service.
Summary by Recall Canary from the FDA notice
What happened
GE Healthcare LLC, of Florence, South Carolina, recalled SIGNA Premier systems, whole-body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease, because the systems may have been manufactured or serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear.
If the system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings, potentially resulting in personnel injury. The company began the recall on February 27, 2026, and the FDA added it to its Enforcement Report on April 2, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
SIGNA Premier systems
- UDI-DI
- 00840682135269
- 00195278010797
- 082427110162
- 082427220143
- 082427020147
- 082427200242
- 082427160461
- 082427250139
- 082427140382
- 15974045
- 11524261
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Massachusetts, New Jersey, New York, Ohio, South Dakota, Texas, Virginia, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of
- Company
- GE Healthcare LLCFlorence, South Carolina
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98579
- Recall number
- Z-1767-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
