The Recall Desk
HighFDA (Devices)·Z-2440-2024·Announced 2024-07-31

Sensis Vibe Cardiac Imaging System Software May Crash During Documentation

Siemens' Sensis Vibe cardiac imaging system software may crash when documentation functionality is used during diagnostic event recording. Two affected systems have been recalled nationwide.

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 an FDA Class II recall involving a medical device where a confirmed software defect creates a risk of application crash during diagnostic use. No illnesses or injuries have been reported. The software failure could disrupt critical cardiac diagnostic procedures, qualifying this as a risk-of-harm product with no reported injury to date.

Plain-English summary

The FDA has issued a recall of Sensis Vibe cardiac imaging systems running software version VD15B in combination with AXIOM Sensis Post Processing Workstation. A potential software flaw exists that may cause the application to crash when the Sensis documentation functionality is used to add once-per-study reporting events during diagnostic studies.

The affected device is manufactured by Siemens Medical Solutions USA, Inc. and is used as a diagnostic and administrative tool for hemodynamic catheterizations and electrophysiology studies in cardiac and interventional radiology procedures. Two systems with serial numbers 18904 and 18906 were distributed nationwide across California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas, and Virginia.

Affected healthcare facilities and operators should contact Siemens Medical Solutions USA, Inc. for guidance regarding this recall and any necessary corrective actions or software updates.

The recalled product

Product
Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as intervention
Manufacturer
Siemens Medical Solutions USA, Inc
Category
Medical Device — Cardiac Imaging Equipment
Hazard
  • software-crash

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: 18904 18906

Distribution

Distributed nationwide across the United States.

Related recalls

Same category