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Open, Classified

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

FDA Recall Z-2734-2024 · Posted 2024-08-27

Recalling FirmSchiller, Ag
Recall StatusOpen, Classified
Product CodeDPS
Date Initiated2024-07-24
Product Quantity1084 untis

Reason for Recall

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

Firm 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.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183425CARDIOVIT AT-102 G2Schiller AG · 2020-03-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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