Agency classClass IIOur severity:Severe FDA (Devices)·Z-0236-2019·Announced 2018-10-31

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: GE Medical Systems, LLC
Category: Medical Device — MRI Scanner
Hazard: burn-injury
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · GE Medical Systems, LLC

See all →

High
Mobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22
High
GE Optima XR200/220/240amx Radiographic System Column Safety Mechanism
FDA (Devices) · 2026-07-22
High
GE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
High
Giraffe OmniBed incubator canopy fasteners can fall into patient compartment
FDA (Devices) · 2026-06-24
High
Giraffe OmniBed replaceable units share the canopy fastener disengagement defect
FDA (Devices) · 2026-06-24

Same hazard · burn injury