CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
This recall is currently active, issued August 27, 2024. It was issued by Schiller, Ag Altgasse 68 Baar Switzerland.
- Recall Initiated
- July 24, 2024
- Posted
- August 27, 2024
- Recall Number
- Z-2734-2024
- Quantity
- 1084 untis
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: 07613365002775. All serial numbers, all software versions.
Root Cause
Software design
Action Taken
Single US consignee was notified via letter on 07/24/2024. The consignee was instructed to send the notification to all consignees if further distributed, respond to the notification and return the reply form, and updated the affected devices according to Service Instructions. At the user level, customer are requested to respond by sending the Customer Reply Form back to their authorized distributor as confirmation that the Field Safety Notice was read and understood.