FDAClass IISeptember 4, 2024

Cardiovit At-180 recall

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

Why was Cardiovit At-180 recalled?

Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 07613365002775. All serial numbers, all software versions.

Product
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Recalling firm
Schiller, Ag
Quantity
1084 untis
Distribution
Worldwide - US distribution in the state of Florida and the countries of Austria, Belgium, Switzerland, Cyprus, Czechia, Germany, Spain, Finland, France, Great Britain, Ireland, Iceland, Italy, Luxembourg, Malta, The Netherlands, Norway, Portugal, Romania, Sweden, Slovenia, Australia, The United Arab Emirates, Bahrain, Canada, China, Israel, India, Jordan, Kuwait, Libya, Morocco, Malaysia, Qatar, Serbia, South Africa.
Recall date
September 4, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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