CT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation
Siemens SOMATOM CT scanners with software syngo CT VA30A_SP4 may experience sporadic software errors causing scanning interruptions and potential unexpected radiation doses. 547 units affected nationwide.
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: This is a risk-of-harm product where software errors could result in unexpected radiation exposure and diagnostic delays. The FDA Class II classification and absence of any reported illnesses or injuries indicate the hazard is theoretical rather than confirmed, supporting a Score 3 rating per the rubric criteria.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 547 SOMATOM CT scanner units with software syngo CT VA30A_SP4, distributed nationwide across multiple models including go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, and X.cite.
A software error may cause sporadic problems including scanning workflow interruptions, unexpected user notifications, and image artifacts during both routine and interventional scanning operations.
The software malfunction may result in potential patient impacts including possible rescans, unexpected X-Ray radiation doses, additional contrast media administration, diagnostic delays, and incomplete scans. No illnesses or injuries have been reported.
Healthcare facilities operating affected units should verify their device's serial number and software version against the FDA recall notice and contact Siemens Medical Solutions USA, Inc. for guidance on corrective measures.
The recalled product
- Product
- SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 547
Distribution
Distributed nationwide across the United States.
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