Sensis Diagnostic System UI Freeze Risk Without Regular System Reboots
Siemens' Sensis diagnostic systems may experience partial UI freezing and fail to update vital signs display if not rebooted at least every 7 days per manufacturer instructions.
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 recall involving a diagnostic system used in clinical procedures where vital signs monitoring is critical. The potential failure to display vital signs presents risk of harm during patient care, meeting the High (3) criterion for risk-of-harm products where injury has not yet been reported. No illnesses, injuries, or actual incidents have been documented.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 403 units of Sensis and Sensis Vibe diagnostic systems nationwide. The affected devices include Sensis (Model 10764561), Sensis Vibe Hemo (Model 11007641), and Sensis Vibe Combo (Model 11007642), all running software version VD1X. These systems are used as diagnostic and administrative tools for hemodynamic catheterizations and electrophysiology studies.
The systems' operator manual specifies that the device should be rebooted once every 7 days. In some cases, users have not followed these instructions and systems have continued running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface, which would no longer update the vital signs display.
Users of affected devices should ensure their systems are rebooted at least once every 7 days as specified in the operator manual to prevent the partial UI freeze that may interrupt vital signs display.
The recalled product
- Product
- Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology stud
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- ui-freeze
- vital-signs-display-failure
Distribution
Distributed nationwide across the United States.
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