Siemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation
Siemens has identified three potential software issues in Sensis programmable diagnostic computers. The issues may prevent treatment from continuing on the device, requiring patients to switch to alternate systems.
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 potential software issues that could prevent treatment continuation. This represents a risk-of-harm scenario without reported illnesses or injuries, meeting the criteria for High severity per the rubric.
Plain-English summary
Siemens Medical Solutions has identified three potential software issues affecting Sensis and AXIOM Sensis programmable diagnostic computers. These software issues may prevent treatment from continuing on the affected device, creating a hazardous situation for patients who would need to continue care on an alternate system.
Approximately 443 units have been distributed nationwide throughout the United States. The affected devices are identified by specific model numbers (including 6623974, 6634633, 6634658, 6648153, 6648161, 10140973, 10764561, 10765502, and 10910620) and serial numbers documented in the FDA recall notice.
Patients and healthcare providers using these systems should be aware of this issue and the potential for treatment interruption. Additional information regarding the software issues and recommended actions should be obtained from Siemens Medical Solutions USA, Inc., or the FDA.
The recalled product
- Product
- Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-malfunction
- treatment-interruption
Distribution
Distributed nationwide across the United States.
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