Sensis Vibe medical diagnostic system software crashes during documentation events
A software issue in certain Siemens Sensis Vibe diagnostic systems may cause the application to crash when documentation features are used during clinical reporting events.
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: FDA Class II medical device with software crash risk during clinical procedures. As a risk-of-harm product used in high-risk settings where no illnesses or injuries have been reported, the theoretical potential for device malfunction warrants a High severity score.
Plain-English summary
The Sensis Vibe is a diagnostic and administrative tool used by healthcare facilities to support catheterizations, electrophysiology studies, and interventional radiology procedures. When the documentation functionality is used during certain administrative reporting events (such as Type 1 events as defined in the administrator manual), the application software may crash.
This defect affects 12 Sensis Vibe systems (software version VD15B) manufactured by Siemens Medical Solutions USA, Inc. The affected devices are distributed across nine US states: California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, and Texas.
Affected users should contact Siemens Medical Solutions USA, Inc for instructions on software updates or remediation. No patient injuries or device-related incidents have been reported. Healthcare facilities using affected units should take precautions to prevent documentation crashes during clinical procedures until the software issue is addressed.
The recalled product
- Product
- Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules,
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-crash
Distribution
Distributed nationwide across the United States.
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