Agency classClass IIOur severity:High FDA (Devices)·Z-2464-2012·Announced 2012-10-03

Siemens MRI Systems Recalled for Potential Coil Heating During Imaging

Siemens is recalling 370 MRI systems because the Flex Large 4 Coil can heat up in the electronic housing when positioned off-center.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential burn injury from heating) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 370 units of the Magnetom Skyra, Verio, Spectra, and Biograph MMR Nuclear Magnetic Resonance Imaging Systems. The recall involves specific model numbers including 10276755, 10684333, 10684334, 10432915, 10655588, and 10433372. These systems were distributed nationwide in the United States, including Washington, DC, and Puerto Rico.

The recall is issued because the Flex Large 4 Coil (part No. 8625761) can heat up in the area of the electronic housing, specifically the white plastic lids, when positioned off-center in the left-right direction and at an off-center position with respect to the head-foot direction. This positioning is used for certain imaging procedures, such as hip and shoulder imaging.

Healthcare facilities and users of these MRI systems should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address this issue. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product: Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — MRI Systems
Hazard: burn-injury
Affected units: 370

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 (6)

Model numbers: 10276755 (Verio)
10684333 (Verio Dot)
10684334 (Verio Dot upgrade)
10432915 (Skyra)
10655588 (Spectra)
and 10433372 (Biograph mMR)

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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