The Recall Desk
HighFDA (Devices)·Z-0919-2017·Announced 2017-01-04

Siemens Recalls SOMATOM Scope CT Systems for Power Cutout Risk

Siemens is recalling 13 SOMATOM Scope CT systems to replace a component that could cause a power cutout during use.

What this means for you

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 medical device with a potential defect that could lead to a power cutout during use, which is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 13 SOMATOM Scope Computed tomography x-ray systems. The recall addresses a potential defect in the Residual Current Monitor (RCM) located in the Line Connection Box (LCB).

The defect could lead to a power cutout during the use of the SOMATOM Scope, Scope Power, and Perspective systems. To resolve this issue, Siemens is providing a new installation of the RCM in the LCB.

The affected systems were distributed to facilities in Illinois, Georgia, South Carolina, South Dakota, Oklahoma, New York, Michigan, Indiana, Maryland, and Arkansas. Specific serial numbers for the 13 affected units are listed in the official recall documentation.

The recalled product

Product
SOMATOM Scope, Computed tomography x-ray system
Affected units
13

Distribution

Distributed in 10 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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Same hazard · power cutout

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