Z-2734-2024 Class II Ongoing
FDA device recall Z-2734-2024 was initiated by Schiller, Ag on July 24, 2024 and is designated Class II. Reason for recall: Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs. The recall status is ongoing. Affected quantity: 1084 untis.
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- July 24, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1084 untis
Product Description
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Reason for Recall
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
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.
Code Information
UDI-DI: 07613365002775. All serial numbers, all software versions.