FDA Medical Device Recalls (openFDA)
Schiller, Ag: CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
- Recall number
- Z-2734-2024
- Recalling firm
- Schiller, Ag
- Product
- CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
- Status
- Open, Classified
- Initiated
- 2024-07-24
- Posted
- 2024-08-27
- Terminated
- not on file
- Reason
- Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
- Root 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
- 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.
- Lot, serial or model codes
- UDI-DI: 07613365002775. All serial numbers, all software versions.
- 510(k) numbers
- ["K183425"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 3002808182
- Firm city
- Baar
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28