Agency classClass IIOur severity:High FDA (Devices)·Z-0996-2022·Announced 2022-05-04

CT scanner software upgrade causes incorrect laser position display

Siemens CT scanner software upgrade may display incorrect laser offset coordinates during patient marking. This defect affects 15 systems in the US across multiple states.

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: FDA Class II recall with no reported illnesses or injuries. The software defect affects a risk-of-harm medical device (CT imaging system with laser positioning) where incorrect coordinate display could impair patient positioning accuracy and clinical decision-making.

Plain-English summary

Siemens Medical Solutions has recalled its syngo.via RT Image Suite software (version VB60) running on SOMATOM go.Sim CT scanners. When the software is upgraded, an automatic change in laser configuration settings for the "markerless workflow" function may cause incorrect laser offset coordinates to be displayed during the Patient Marking step.

This defect could affect the accuracy of patient positioning and marking during imaging procedures. The recall affects 15 systems distributed across 20 US states and 14 countries worldwide.

If you operate an affected system, contact your Siemens representative for instructions on correcting the laser configuration settings. Do not rely on laser offset coordinates displayed on the system until the issue is resolved.

The recalled product

Product: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Manufacturer: Siemens Medical Solutions USA, Inc
Category: Medical Device — Diagnostic Imaging / CT Scanner
Hazard: software-defect
coordinate-error
mis-calibration
Affected units: 15

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 (16)

Partial UDI: 04056869249230
Serial Numbers 128123
128106
128109
128144
128124
128112
128132
128135
128114
128125
128113
128142
128107
128136
128133

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Same manufacturer · Siemens Medical Solutions USA, Inc

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