Siemens CT Scanners: Software Errors May Interrupt Scanning Workflows
Siemens SOMATOM CT systems with certain software versions may experience sporadic errors causing workflow interruptions and diagnostic delays. Affected systems should be updated to prevent scan aborts and patient rescans.
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 is an FDA Class II medical device recall affecting operational function with potential for diagnostic delay. While no patient injuries or illnesses have been reported, the identified software errors create actual risk of harm through delayed or aborted scans requiring patient rescans.
Plain-English summary
Siemens Medical Solutions has recalled 31 CT scanning systems with specific software versions due to sporadic software errors. The affected systems include SOMATOM go.Up, go.All, go.Top, and X.cite models.
The software errors in versions syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3, and VA30A_FP2 may cause unexpected notifications, scanning workflow interruptions, and diagnostic delays. In some cases, scans may abort, requiring patient rescans.
Siemens is distributing remote and onsite software updates to correct the problem. Affected facilities should contact Siemens Medical Solutions USA, Inc. to install the appropriate software update for their system model and current software version.
The recalled product
- Product
- Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATO
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-defect
- diagnostic-delay
- workflow-interruption
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 (20)
- US Serial Numbers: 111307
- 111526
- 119328
- 108158
- 123104
- 111219
- 123054
- 117633
- 111566
- 111427
- 123059
- 117558
- 117533
- 119317
- 117647
- 108088
- 123060
- 123118
- 123055
- 111518
Distribution
Distributed nationwide across the United States.
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