Device product
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Z-2734-2024
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
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.