Siemens Sensis Vibe Systems Recalled for Software Error in Report Generation
Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.
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 where incorrect diagnosis or treatment is possible, but the source explicitly states the error does not result in a hazardous situation and no injuries are reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 13 units of Sensis Vibe Systems with Software Version VD10B. The affected model numbers are 10765502, 10910620, 11007641, and 6648161. These programmable diagnostic computers were distributed in the United States to the states of Indiana, Michigan, and Iowa.
The recall is due to a software error that can cause problems generating reports or result in information from different examinations of the same patient being combined into one report. The source text states that this error does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, it can potentially result in an incorrect treatment or diagnosis.
No specific instructions for consumers are provided in the source text, as the devices are distributed to healthcare facilities.
The recalled product
- Product
- Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 13
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 (1)
- Software Version VD10B
Distribution
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