Quick Facts at a Glance
- Recall Date
- February 27, 2026
- Hazard Level
- HIGH
- Brand
- GE Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE Healthcare
- Product type
- MRI System
- Model numbers
- UDI-DI/GTIN: 00840682135269, 00195278010797. System ID: 415353UMR2, 415723SHMR19, 413253MR3T, 908725MR, 609652MR3T, M48823, 7168453T +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 27, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 15, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Healthcare LLC or your healthcare provider for instructions
Why This Is Dangerous
Ferrous fittings may be used where non-ferrous fittings should be. During service with the magnet ramped, magnetic attraction could cause injury to personnel.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The impact is operational disruption for facilities with SIGNA Premier MRI systems. The recall affects 41 units globally, with US distribution across multiple states. Hospitals must halt use and coordinate with GE Healthcare for next steps.
Practical Guidance
How to identify if yours is affected
- 1. Stop using the device.
- 2. Locate model number, system ID, and UDI/GTIN on the device label.
- 3. Compare against the recall model list and IDs.
- 4. Contact GE Healthcare or your healthcare provider for instructions.
- 5. Follow the recall process and do not service outside approved procedures.
Where to find product info
Model numbers, system IDs, and UDI/GTIN can be found on the device label and in the procurement documentation. The recall list includes the items under existingModels in the notice.
What timeline to expect
Refunds or replacements are not detailed; facilities should expect guidance from GE Healthcare and plan accordingly.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact GE Healthcare customer support via the official site
- File a report with the local regulatory authority if needed
How to prevent similar issues
- Verify recalls before service
- Engage only GE-authorized service providers for MRI systems
- Maintain a current inventory of devices and cross-check against recall notices
- Document all service events and verify non-ferrous fittings in future hardware upgrades
Documentation advice
Keep copies of the recall notice, all communications with GE Healthcare, serial numbers, IDs, and any replacement or service orders
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Product Details
Brand: GE Healthcare Product: SIGNA Premier Whole-Body MRI System Units recalled: 41 Sold worldwide; US distribution includes CA, MA, NJ, NY, OH, SD, TX, VA, PR Countries affected include Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic of (South Korea) Recall date: 2026-02-27 FDA recall number: Z-1767-2026 Model/ID references include: UDI-DI/GTIN: 00840682135269; System IDs and model strings listed in the recall notice Remedy: Stop use and follow manufacturer recall instructions Manufacturer: GE Healthcare LLC
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Worldwide distribution; US states listed: CA, MA, NJ, NY, OH, SD, TX, VA, PR
- Model/ID references include 00840682135269 and multiple system IDs
- Hazard: ferrous fittings on magnet rear could be attracted during ramped service
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Safety Guide
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