The Recall Desk
HighFDA (Devices)·Z-1300-2016·Announced 2016-04-06

Siemens CT Systems Recalled for Potential Malfunction Hazard

Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

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 potential hazard to patients and personnel from a malfunctioning medical device, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 124 units of the SOMATOM Emotion and SOMATOM Sensation families of CT systems. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.

The recall is initiated due to a potential malfunction that presents a potential hazard to patients and personnel when the systems are used in conjunction with the cardio licenses "Cardio Pro" and "Cardio Retro." The affected units were distributed nationwide in the US, including Guam and 29 specific states.

Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the potential malfunction.

The recalled product

Product
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — CT Systems
Hazard
Affected units
124

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)

  • Model Number # SOMATOM Emotion 6 - 3815490

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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