GE Signa Architect MRI Scanner Recall: Risk of Serious Burns from Warm Bore Surface
GE Medical Systems recalls Signa Architect MRI systems with specific serial numbers due to potential serious burns if patient touches warm bore surface without proper padding. Affected units may need safety adjustments.
Use caution until it’s fixed
A small area on the bore surface, which is normally accessible to the patient, can get warm enough to cause a serious burn in the event the patient touches the bore and proper padding is not used.
Contact the company
What happened, in plain English
GE Medical Systems is recalling certain Signa Architect MRI scanners because a small area on the bore surface can get warm enough to cause serious burns if the patient touches it without proper padding. This hazard affects patients during scans and requires immediate attention to prevent injury. Read more at govinfonow.com/recall/69672-ge-signa-architect-mri-scanner-recall-risk-of-serious-burns.
Source Summary by GovInfoNow · govinfonow.com/recall/69672-ge-signa-architect-mri-scanner-recall-risk-of-serious-burns · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0236-2019
Cite this page
“GE Signa Architect MRI Scanner Recall: Risk of Serious Burns from Warm Bore Surface.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69672-ge-signa-architect-mri-scanner-recall-risk-of-serious-burns. Based on FDA recall #Z-0236-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0236-2019%22&limit=1).
Why it’s dangerous
The bore surface of the MRI scanner can become warm enough to cause serious burns if a patient touches it during a scan without proper padding. This occurs because the magnetic field interacts with the patient's body in a way that generates heat in a specific area of the bore.
Who’s affected
Patients undergoing MRI scans with the affected Signa Architect systems are at risk of serious burns if they touch the warm bore surface without proper padding. Healthcare providers using these systems should verify the serial numbers to identify affected units.
How to tell if you have this one
Check for the serial numbers: U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), or U30RF0268B (A020MR05) on the system's label. The Signa Architect system is a whole-body MRI scanner used for diagnostic imaging.
- Brand
GE Medical Systems- Category
Medical device
What to do — step by step
Check Serial Numbers
Look for the serial numbers listed: U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), or U30RF0268B (A020MR05) on the system's label.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide Distribution in the state of Utah. International distribution to France, Republic of Korea, and Sweden.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0236-2019 (October 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0236-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.