Recall Z-2734-2024 ยท DPS Electrocardiograph
Schiller, Ag
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
| Date | Aug 27, 2024 (initiated Jul 24, 2024) |
| Status | Open, Classified |
| 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 Ara |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183425 | CARDIOVIT AT-102 G2 Schiller AG, Mar 2, 2020 |