Agency classClass IIOur severity:High FDA (Devices)·Z-2344-2019·Announced 2019-08-28

Siemens MAGNETOM Spectra MRI Devices Recalled for Quench Venting Port Issue

Siemens Medical Solutions is recalling two MAGNETOM Spectra MRI devices due to a potential open port in the quench venting system.

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 structural defect in a medical device (open port in venting system) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling two units of the MAGNETOM Spectra magnetic resonance diagnostic device, Model # 10837643. The affected units have serial numbers 72030 and 72023.

The recall is due to a potential open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. This defect could affect the safety of the device's venting mechanism.

The devices were distributed to facilities in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia, and Wyoming. Users of these devices should contact Siemens Medical Solutions USA, Inc. for further instructions.

The recalled product

Product: MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — MRI Scanner
Hazard: structural-defect
venting-failure
Affected units: 2

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 (1)

Serial # 72030 72023

Distribution

Distributed in 42 states:

Part of a larger recall action

This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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