Schiller, Ag: CARDIOVIT AT-180 Electrocardiographs Recalled for ECG Signal Artifacts

Agency Publication Date: August 27, 2024

Summary

Schiller, Ag has recalled 1,084 units of the CARDIOVIT AT-180 electrocardiograph device because the machines may record high-frequency signal artifacts during an ECG acquisition. This defect involves all serial numbers and software versions for model number 0A.110000. These artifacts can interfere with the clarity of the heart readings, potentially impacting the accuracy of patient assessments.

Risk

The recording of signal artifacts can distort the electrocardiograph results, which may lead to incorrect data interpretation by medical professionals. This could result in a delayed or incorrect diagnosis for patients undergoing heart monitoring.

What You Should Do

Identify your device by checking for the CARDIOVIT AT-180 name and Model Number 0A.110000 (Catalog number 3.920570) on the equipment label.
Verify if your unit is affected by checking the UDI-DI 07613365002775; note that this recall applies to all serial numbers and all software versions of this specific model.
Contact your healthcare provider or Schiller, Ag directly at the manufacturer's headquarters in Switzerland to receive further instructions regarding this voluntary notification and potential corrective actions.
For additional questions or to report issues, 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

Other Action

Manufacturer Notification and Support

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

Affected Products

Product: CARDIOVIT AT-180 Electrocardiograph

Model / REF:

0A.110000

3.920570

UPC Codes:

07613365002775

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95074

Status: Active

Manufacturer: Schiller, Ag

Sold By: authorized distributors

Manufactured In: Switzerland

Units Affected: 1084 untis

Distributed To: 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 · 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.

Summary

What You Should Do

Identify your device by checking for the CARDIOVIT AT-180 name and Model Number 0A.110000 (Catalog number 3.920570) on the equipment label.

Verify if your unit is affected by checking the UDI-DI 07613365002775; note that this recall applies to all serial numbers and all software versions of this specific model.

Contact your healthcare provider or Schiller, Ag directly at the manufacturer's headquarters in Switzerland to receive further instructions regarding this voluntary notification and potential corrective actions.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.