The Recall Desk
HighFDA (Devices)·Z-0921-2017·Announced 2017-01-04

Siemens Recalls CT Systems for Potential Power Cutout Defect

Siemens is recalling 13 SOMATOM Perspective CT systems to replace a component that could cause power cutouts 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential operational failure during use.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 13 SOMATOM Perspective computed tomography x-ray systems. The recall addresses a potential defect in the Residual Current Monitor (RCM) located in the Line Connection Box (LCB). This defect could lead to a power cutout during the use of the equipment.

The affected systems were distributed to facilities in Illinois, Georgia, South Carolina, South Dakota, Oklahoma, New York, Michigan, Indiana, Maryland, and Arkansas. Siemens is providing a new installation of the RCM in the LCB to resolve the issue.

Healthcare facilities should contact Siemens to schedule the replacement of the component. The recall also covers SOMATOM Scope and Scope Power systems, though the specific quantity for those models is not detailed in this notice.

The recalled product

Product
SOMATOM Perspective, 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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