Sensis Vibe Hemo Medical Device Software May Crash
Siemens is recalling 331 units of the Sensis Vibe Hemo medical device due to a potential software crash in its documentation functionality application. Units affected are distributed in California, Connecticut, and Florida.
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 Class II medical device recall involves a software functionality risk that could affect clinical documentation access. While no injuries or actual crashes have been reported, the potential impact on medical device functionality qualifies this as a risk-of-harm product, meeting the High severity threshold per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Sensis Vibe Hemo medical device due to the possibility that its documentation functionality application may crash.
The recall affects 331 units of model number 11007641 with specific serial numbers. The affected units have been distributed domestically in California, Connecticut, and Florida.
If the documentation functionality crashes, users may lose access to that application functionality. No injuries or actual crashes have been reported. Users of affected devices should contact Siemens Medical Solutions USA, Inc. for additional information and guidance.
The recalled product
- Product
- Sensis Vibe Hemo
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device
- Affected units
- 331
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 (11)
- Model No. 11007641
- UDI-DI 04056869010199
- Serial No. 18009
- 106245
- 18016
- 18014
- 18011
- 18010
- 19001
- 106244
- 18015.
Distribution
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