Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Medical Solutions USA, Inc: Sensis Vibe Systems Recalled Due to Potential Software Application Crash

Agency Publication Date: July 25, 2024
Share:
Sign in to monitor this recall

Summary

Siemens Medical Solutions USA, Inc. has recalled 24 units of its Sensis Vibe systems equipped with software version VD15B. These medical devices, used during heart catheterizations and radiology procedures, can experience an application crash if certain documentation functions are used while recording specific clinical events. This software failure could lead to delays in critical medical procedures or loss of documentation during a surgery or diagnostic study.

Risk

If the software crashes during a medical procedure, it can interrupt the monitoring and documentation of vital patient data. This poses a risk of procedure delays or technical failures while a patient is undergoing an invasive cardiovascular or radiological intervention.

What You Should Do

  1. Identify your device by checking for Sensis Vibe systems running software version VD15B on your Sensis High End Server, VM Virtual Server, or AXIOM Sensis Post Processing Workstation.
  2. Verify the serial number on your unit to see if it is one of the affected models, including serial numbers 15000, 15001, 15003, 18023, 18022, 18020, 18021, 18019, 18025, 18017, 18904, 18906, 18009, 18010, 18011, 18014, 18015, 18016, 19001, 103584, 103596, 104064, 106244, 106245, or 102183.
  3. Be aware that the crash specifically occurs when using documentation functionality while adding 'once-per-study' reporting events (Type 1 events) as defined in your administrator manual.
  4. Contact your Siemens Medical Solutions representative or healthcare facility administrator for guidance on software updates or mitigation steps.
  5. Healthcare providers should contact Siemens Medical Solutions USA, Inc. at 40 Liberty Blvd, Malvern, PA 19355 for further technical instructions.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact your healthcare provider or the manufacturer for further instructions and potential refund

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Sensis Vibe systems with software version VD15B in combination with Sensis High End Server
Model / REF:
10910620
Lot Numbers:
Serial Numbers: 15000 15001 15003
Product: Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER
Model / REF:
10765502
Lot Numbers:
Serial Numbers: 18023 18022 18020 18021 18019 18025 18017
Product: Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation
Model / REF:
6648161
Lot Numbers:
Serial Numbers: 18904 18906
Product: Sensis Vibe systems with software version VD15B
Model / REF:
11007641
UPC Codes:
4056869010199
Lot Numbers:
Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 102183

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94956
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Direct distribution to hospitals and clinics
Manufactured In: United States
Units Affected: 4 products (3 systems; 7 systems; 2 systems; 12 units)
Distributed To: California, Connecticut, Florida, Iowa, Kansas, Massachusetts, Michigan, New Jersey, Texas, Virginia
Agency Last Updated: August 26, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.