FDA recall Z-2734-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-07-24

Report date

2024-09-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baar, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2734-2024