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.
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: 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software crash
See all →- HighFlow cytometers recalled over software that crashes during sample acquisition
FDA (Devices) · 2025-11-26
- HighSensis Vibe diagnostic systems software crash during event documentation
FDA (Devices) · 2024-07-31
- HighSensis Vibe Cardiac Imaging System Software May Crash During Documentation
FDA (Devices) · 2024-07-31
- HighSensis Vibe medical diagnostic system software crashes during documentation events
FDA (Devices) · 2024-07-31
- ModerateMedical device diagnostic software vulnerability causes potential application crashes
FDA (Devices) · 2024-07-31
Similar recalls
- HighSiemens Sensis Vibe Systems Recalled for Software Error in Report Generation
FDA (Devices) · 2017-07-12
- HighSiemens Sensis Diagnostic Computer: Software Issues May Prevent Treatment Continuation
FDA (Devices) · 2022-06-15
- ModerateMedical device diagnostic software vulnerability causes potential application crashes
FDA (Devices) · 2024-07-31
- HighSensis Vibe medical diagnostic system software crashes during documentation events
FDA (Devices) · 2024-07-31
- HighFDA Recalls Sensis Cardiac Diagnostic Systems for Software Measurement Error
FDA (Devices) · 2022-01-26
- HighSiemens CentraLink Software Recall for Potential Patient Data Release Error
FDA (Devices) · 2014-01-29