Agency classClass IIOur severity:High FDA (Devices)·Z-1448-2018·Announced 2018-05-09

Siemens SOMATOM Perspective 16 CT Scanner Recalled for Dose Calculation Error

Siemens is recalling 1,301 SOMATOM Perspective 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

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-harm product (unnecessary radiation exposure) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Perspective 16 CT scanner. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall was initiated to inform customers of a potential issue with the CARE Dose4D algorithm.

The CARE Dose4D algorithm may incorrectly calculate tube current for head scans based on posterior-anterior (p.a.) or anterior-posterior (a.p.) topograms. Depending on the geometrical shape of the skull bone, the calculated dose distribution may be inappropriate in rare cases. This error could lead to unnecessary radiation exposure for patients.

The affected units were distributed nationally in the United States. Customers should contact Siemens Medical Solutions USA, Inc. for further information regarding the recall and corrective actions.

The recalled product

Product: SOMATOM Perspective 16 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)

10046734

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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