FDAFDA · Food and drugs·Recall number Z-2734-2024
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Published September 4, 2024 · Recall initiated: July 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Schiller, Ag
- Distributor
- 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.
- Lot
- UDI-DI: 07613365002775. All serial numbers, all software versions.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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