Sensis diagnostic tool software may fail to display vital signs
Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.
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 device with risk of diagnostic failure due to software communication issue preventing vital sign display. No hospitalizations, injuries, or deaths reported, making this score 3 per the rubric.
Plain-English summary
Siemens Medical Solutions is recalling 2 units of the Sensis diagnostic tool (software version VD12A, Model 10764561) used in cardiac catheterization and interventional radiology procedures. Serial numbers 61331 and 60015 are affected.
The device may experience a communication disconnect in the ComboBox component during the first patient examination of the day or after an extended period of inactivity. When this occurs, vital signs become unavailable to the clinical team.
This device was distributed nationwide to facilities in Arizona, Florida, Kentucky, Michigan, Ohio, Puerto Rico, and Texas. Healthcare providers using affected units should contact Siemens Medical Solutions for software updates and instructions.
The recalled product
- Product
- Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 2
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 (2)
- UDI-DI: 04056869010137 Serial Numbers: 61331
- 60015
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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