Class 2 Device Recall CARDIOVIT AT180

• Date Initiated by Firm: July 24, 2024
• Date Posted: August 27, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2734-2024
• Recall Event ID: 95074
• 510(K)Number: K183425
• Product Classification: Electrocardiograph - Product Code DPS
• Product: CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
• Code Information: UDI-DI: 07613365002775. All serial numbers, all software versions.
• FEI Number: 3002808182
• Recalling Firm/ Manufacturer: Schiller, Ag; Altgasse 68; Baar Switzerland
• Manufacturer Reason for Recall: Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
• FDA Determined Cause: Software design
• Action: 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.
• Quantity in Commerce: 1084 untis
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DPS