Recall Z-2734-2024
Schiller, Ag · initiated July 24, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Codes / lots: UDI-DI: 07613365002775. All serial numbers, all software versions.
Reason for recall
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
FDA-determined cause: Software design
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.
Details
- Recall number
- Z-2734-2024
- Initiated
- July 24, 2024
- Posted by FDA
- August 27, 2024
- Product code
- DPS – Electrocardiograph
- 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…
- Recalling firm
- Schiller, Ag, Baar