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.
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.
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.
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.
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.
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.
Look for the serial numbers listed: U30RF0251B (801588MR3), U30RF0258B (M4040093), U30RF0275B (850270504), or U30RF0268B (A020MR05) on the system's label.
The Signa Architect system has a small area on the bore surface that can get warm enough to cause serious burns if the patient touches it without proper padding during a scan.
Check the serial numbers listed in the recall notice to see if your system is affected. If it is, contact GE Medical Systems for guidance.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0236-2019 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-0236-2019 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
