CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Recall
- Recall Number
- Z-2734-2024
- Event Number
- 95074
- Firm
- Schiller, Ag Altgasse 68 Baar Switzerland
- FEI Number
- 3002808182
- Product Code
- DPS
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- July 24, 2024
- Posted
- August 27, 2024
Description
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
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.
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.
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