Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2734-2024

July 24, 2024

Class II

Product summary

Firm
Schiller, Ag
Event
Event 95074
Status
Ongoing
Classification
Class II
Quantity
1084 untis
Official record key
device-enforcement:Z-2734-2024

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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