← Search recalls
FDA (Device enforcement)Recalled 2022-03-07closedclass ii

Siemens Medical Solutions USA, Inc: 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 scan

Is my product affected?

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.

  • UPC 04056869249230

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions has recalled 15 SOMATOM go.Sim CT scanner systems in the United States that were upgraded to syngo.via RT Image Suite VB60 software. When the software was upgraded, it automatically changed the laser configuration settings for "markerless workflow," which can cause incorrect laser offset coordinates to be displayed during the Patient Marking step of CT scanning procedures.

The affected systems are located in 20 U.S. states and have specific serial numbers ranging from 128106 to 128144. The recall also affects systems distributed in multiple countries including Canada, the United Kingdom, Japan, and others. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

Details from the source

Reason for recall: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step. Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom. Quantity: 15 (US) Lot/code info: Partial UDI: 04056869249230, Serial Numbers 128123, 128106, 128109, 128144, 128124, 128112, 128132, 128135, 128114, 128125, 128113, 128142, 128107, 128136, 128133

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

All FDA (Device enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify