Agency classClass IIOur severity:High FDA (Devices)·Z-1458-2018·Announced 2018-05-09

Siemens SOMATOM Sensation 40 CT Scanner Recalled for Dose Calculation Error

Siemens is recalling 1,301 SOMATOM Sensation 40 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.

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 risk of unnecessary radiation exposure, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Sensation 40 CT scanner. The device is intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. The recall is due to possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on posterior-anterior or anterior-posterior topograms.

Depending on the geometrical shape of the skull bone, the calculated dose distribution may be inappropriate in rare cases. This could lead to unnecessary radiation exposure for patients. The affected units were distributed nationally in the United States.

Consumers and healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the issue. The recall is classified as Class II by the FDA.

The recalled product

Product: SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — CT Scanner
Hazard: radiation-exposure
Affected units: 1,301

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)

8874427

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 15 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 15 products in this recall →

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