Medical device diagnostic software vulnerability causes potential application crashes
Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a potential software crash scenario. The source describes only the possibility of application crash with no documented incidents of system failure.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling seven Sensis Vibe systems (Model 10765502) with software version VD15B due to a software vulnerability that may cause the application to crash.
The issue occurs when the documentation functionality is used while adding once-per-study reporting events during hemodynamic catheterizations or electrophysiology studies. When this specific combination of actions is performed, the system has the potential to crash, interrupting the diagnostic or administrative workflow.
Seven affected systems were distributed nationwide to facilities in California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas, and Virginia. The affected serial numbers are 18023, 18022, 18020, 18021, 18019, 18025, and 18017.
Healthcare facilities and clinicians using these systems should contact Siemens for a software update or further guidance.
The recalled product
- Product
- Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-crash
- system-malfunction
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 (1)
- UDI-DI: N/A Serial Numbers: Serial 18023 18022 18020 18021 18019 18025 18017
Distribution
Distributed nationwide across the United States.
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