The Recall Desk
HighFDA (Devices)·Z-0285-2022·Announced 2021-12-01

Siemens CT Scanner Software May Cause Diagnostic Workflow Delays

Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.

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: Class II recall with software defect affecting diagnostic workflow and capability. No hospitalizations or injuries reported, but the defect poses a risk-of-harm through potential diagnostic delays. Meets criteria for High severity as a risk-of-harm product without reported injury.

Plain-English summary

Siemens Medical Solutions USA is recalling 298 SOMATOM Definition Edge CT scanners (Model #10590000) with syngo.CT VB20 software nationwide. The software may cause workflow interruptions during normal operation.

When interruptions occur, they can result in delays in patient diagnosis, the necessity for repeat patient scans, and the need for additional contrast media. These workflow issues impact diagnostic capability and patient care efficiency.

Healthcare facilities using affected units should contact Siemens Medical Solutions immediately regarding available software updates and remediation options. Affected serial numbers are provided by the FDA. Healthcare providers should assess their use of these systems and implement corrective measures to prevent diagnostic delays.

The recalled product

Product
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Diagnostic Imaging / CT Scanner
Hazard
  • software-defect
  • diagnostic-delay
  • workflow-interruption

Distribution

Distributed nationwide across the United States.

Related recalls

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