Programmable Diagnostic Computer Software Update Addresses Crash Errors
Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.
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 recall of a medical diagnostic device with software errors that could prevent operation during procedures. No illnesses or injuries reported; the hazard is operational disruption rather than direct patient harm, meeting the criteria for score 3 as a risk-of-harm product without reported injury.
Plain-English summary
Siemens Medical Solutions is performing a software update to correct four identified errors in the Programmable Diagnostic Computer (Sensis models with software version VD12A). Approximately 638 units were distributed in the United States, with 2,213 units distributed worldwide.
The software errors include: a "PASSWORD STORE CORRUPTED" error message during system startup that may delay or interrupt procedures; subsystem crashes during examinations; application crashes while loading studies; and internal timeouts causing system crashes. These issues may prevent operators from starting or continuing diagnostic examinations.
The manufacturer will perform a software update to address all four potential issues.
The recalled product
- Product
- Programmable Diagnostic Computer
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- software-crash
- device-malfunction
- diagnostic-disruption
Distribution
Distributed nationwide across the United States.
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