The Recall Desk
HighFDA (Devices)·Z-2438-2024·Announced 2024-07-31

Sensis Vibe diagnostic systems software crash during event documentation

Siemens Sensis Vibe diagnostic systems may crash when using documentation features during once-per-study event reporting. Three systems are affected; no injuries reported.

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: This is a medical device used in critical cardiac and interventional procedures. The software crash during documentation functionality represents a risk-of-harm product where injury has not yet been reported, meeting the Score 3 criterion. No illnesses or injuries have been reported, precluding a higher score despite the Class II classification.

Plain-English summary

Siemens Medical Solutions has issued a recall for three Sensis Vibe systems with software version VD15B. These systems are used as diagnostic and administrative tools supporting hemodynamic catheterizations, electrophysiology studies, cardiac imaging, interventional radiology, and surgical procedures.

The recall addresses a software defect where the application may crash if the documentation functionality is used when adding once-per-study reporting events, such as Type 1 events as defined in the administrator manual. This crash could disrupt the system's ability to document and report critical events during procedures.

The affected systems are identified by serial numbers 15000, 15001, and 15003. These systems have been distributed nationwide to facilities in California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas, and Virginia.

Facilities using these systems should contact Siemens Medical Solutions for guidance on updating to a corrected software version or for instructions on workarounds to prevent the crash. Do not use the documentation functionality for once-per-study event reporting until the issue is resolved.

The recalled product

Product
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as wel
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Cardiac diagnostic systems
Hazard
  • software-crash
  • documentation-failure

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)

  • UDI-DI: N/A Serial Numbers: 15000 15001 15003

Distribution

Distributed nationwide across the United States.

Related recalls

Same category