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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.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Siemens Medical Solutions USA, Inc: Sensis Vibe Hemo Recalled Due to Potential Application Crashes

Agency Publication Date: January 9, 2024
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Summary

Siemens Medical Solutions USA, Inc. has recalled 331 units of its Sensis Vibe Hemo documentation system due to a software issue that can cause the application to crash. This device is used in medical settings to document hemodynamic data during cardiac procedures. If the software fails during a procedure, medical staff may lose the ability to document critical patient data or monitor vital signs through the system. Consumers should contact their healthcare provider or the manufacturer to ensure their systems receive the necessary software updates or technical support.

Risk

A software crash during a medical procedure can lead to a delay in treatment or the loss of clinical documentation, potentially impacting patient safety if vital information is not available to the clinical team during a cardiac intervention.

What You Should Do

  1. Identify if your facility is using the Sensis Vibe Hemo system with Model Number 11007641 and UDI-DI 04056869010199.
  2. Verify the device serial number against the affected list: 18009, 106245, 18016, 18014, 18011, 18010, 19001, 106244, or 18015.
  3. Check for the official notification letter sent by Siemens Medical Solutions USA, Inc. on or around November 29, 2023, which contains specific technical instructions.
  4. Contact your healthcare provider or Siemens Medical Solutions USA, Inc. at 40 Liberty Blvd, Malvern, Pennsylvania, 19355-1418 for further instructions and information on necessary software patches or service.
  5. For additional questions or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for technical support.

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

Affected Products

Product: Sensis Vibe Hemo
Model / REF:
11007641
UDI-DI 04056869010199
Lot Numbers:
Serial No. 18009
Serial No. 106245
Serial No. 18016
Serial No. 18014
Serial No. 18011
Serial No. 18010
Serial No. 19001
Serial No. 106244
Serial No. 18015

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93637
Status: Active
Manufacturer: Siemens Medical Solutions USA, Inc
Sold By: Siemens Medical Solutions USA, Inc
Manufactured In: United States
Units Affected: 331 units
Distributed To: California, Connecticut, Florida

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.