GE Medical Systems Recalls Signa Architect MRI Scanners Due to Burn Risk
GE Medical Systems is recalling four Signa Architect MRI scanners because a small area on the bore surface can get warm enough to cause a serious burn if proper padding is not used.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of serious injury (burns), which aligns with the rubric criteria for a Severe rating.
Plain-English summary
GE Medical Systems, LLC is recalling four units of the Signa Architect system, a whole-body magnetic resonance scanner. The recall is due to a safety hazard where a small area on the bore surface, which is normally accessible to the patient, can become warm enough to cause a serious burn if the patient touches the bore and proper padding is not used.
The affected units were distributed worldwide, including nationwide distribution in the state of Utah and international distribution to France, the Republic of Korea, and Sweden. The specific units are identified by model number 5388807-100 and the following serial numbers: U30RF0251B, U30RF0258B, U30RF0275B, and U30RF0268B.
Healthcare facilities should stop using the affected units and contact GE Medical Systems for instructions on how to resolve the issue, including the proper use of padding to prevent patient contact with the warm bore surface.
The recalled product
- Product
- SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI Scanner
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model number: 5388807-100
- Serial number (System ID number ): U30RF0251B (801588MR3)
- U30RF0258B (M4040093)
- U30RF0275B (850270504)
- U30RF0268B (A020MR05)
Distribution
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