Schiller, Ag: Device Recall

Recall #Z-2734-2024 · 07/24/2024

Class II: Risk

Recall Details

Recall Number: Z-2734-2024
Classification: Class II
Product Type: Device
Recalling Firm: Schiller, Ag
Status: Ongoing
Date Initiated: 07/24/2024
Location: Baar, Switzerland
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1084 untis

Reason for Recall

Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

Product Description

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

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.

Other Recalls by Schiller, Ag

Class II: Risk 08/08/2025

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

View all recalls by Schiller, Ag →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.