CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
FDA device recall Z-2734-2024 · posted 2024-08-27 · Open, Classified
Recall details
- Recalling firm
- Schiller, Ag
- Reason for recall
- Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 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, Luxemb
- Date initiated
- 2024-07-24
- Date posted
- 2024-08-27
- Location
- Baar, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOVIT AT-102 G2 (K183425) | Schiller AG | 2020-03-02 |