The Recall Desk
ModerateFDA (Devices)·Z-2342-2019·Announced 2019-08-28

Siemens MAGNETOM Aera MRI Devices Recalled for Quench Venting System Port Issue

Siemens Medical Solutions USA is recalling 143 MAGNETOM Aera MRI devices due to a potential open port in the quench venting system when using the optional horizontal outlet.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or deaths. The hazard is a potential mechanical defect (open port) without confirmed adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 143 units of the MAGNETOM Aera magnetic resonance diagnostic devices (Model # 10432914). The recall is due to a potential open port in the quench venting system that may occur when using the optional horizontal outlet on the quench line assembly.

The affected devices were distributed to facilities in 41 states and the District of Columbia, including Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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. Specific serial numbers for the affected units are listed in the official recall documentation.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address this issue. Consumers and patients should consult their healthcare provider if they have questions regarding their recent MRI scans.

The recalled product

Product
MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
Affected units
143

Distribution

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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