Z-2734-2024 Class II Ongoing

Recalled by Schiller, Ag — Baar

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.