Siemens Sensis Systems Recalled for Windows Service Permission Vulnerability
Siemens Medical Solutions is recalling Sensis and Sensis Vibe Hemo systems due to Windows Service Permission configuration risks that could expose sensitive information or allow data manipulation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (medical device) where the hazard is the potential for incorrect diagnostic or therapeutic decisions due to data manipulation or exposure, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 99 units of Sensis and Sensis Vibe Hemo systems equipped with VD12A software. The affected systems include various server and workstation configurations distributed nationwide in the United States.
The recall is due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis and Sensis Vibe computers. This configuration creates a risk for the exposure of sensitive information, manipulation of data, or Denial of Service attacks. Such security vulnerabilities could potentially result in incorrect diagnostic or therapeutic decisions.
Healthcare facilities and users of these systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the configuration issue. The recall number is Z-1434-2021.
The recalled product
- Product
- Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo…
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 99
Distribution
Distributed nationwide across the United States.
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