FDA Enforcement
Class II
Ongoing
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Recall: Z-2734-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2734-2024
- Event ID
- 95074
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Schiller, Ag
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- July 24, 2024
- Classification Date
- August 27, 2024
- Address
- Altgasse 68, Baar, N/A, Switzerland
Description
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Reason
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
Code Info
UDI-DI: 07613365002775. All serial numbers, all software versions.
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.
Quantity
1084 untis