CT Scanner Software May Cause Workflow Delays and Patient Rescans
Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.
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: This FDA Class II medical device recall involves software that may cause workflow interruptions and delayed diagnoses. Although no patient injuries have been reported, diagnostic delays in medical imaging pose an inherent risk of harm, placing this under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the SOMATOM Edge Plus CT scanner (Model #10267000) equipped with syngo.CT software version VB20, with or without subsequent patches (SP1, SP2, SP3, or SP4). A total of 64 units have been distributed nationwide.
The software may cause workflow interruptions during normal operation. These interruptions can result in delayed diagnoses, the need for additional patient imaging scans, and potentially greater use of contrast media during procedures.
The recall affects CT scanners installed at healthcare facilities across the United States. Facilities using affected serial numbers should contact Siemens Medical Solutions for guidance.
Healthcare providers with affected units should review the list of affected serial numbers and contact Siemens Medical Solutions USA, Inc. for instructions on software updates or other remedial measures.
The recalled product
- Product
- SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-defect
- workflow-interruption
- diagnostic-delay
Distribution
Distributed nationwide across the United States.
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