CARDIOVIT AT-180. Model Number: 0A.110000 recallZ-2734-2024 · Schiller, Ag · initiated Jul 24, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Schiller, Ag or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2734-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 24, 2024
- Posted by the FDA
- Aug 27, 2024
- Recalling firm
- Schiller, Ag
- Quantity
- 1084 untis
- Product code
- DPS
- FDA submissions
- K183425
- 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.
Product description
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Code information (models, lots, serial numbers)
UDI-DI: 07613365002775. All serial numbers, all software versions.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CARDIOVIT AT-180 3.920570Schiller AG · Electrocardiograph1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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