Z-2734-2024Class II

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570

Name: Z-2734-2024 CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Creator: Schiller, Ag
Published: 2024-07-24
License: https://open.fda.gov/license/

Schiller, AG / initiated 2024-07-24 / Open, Classified / root cause: software

FDA source

Schiller, Ag began a recall of CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 on 2024-07-24. FDA classified it as Class II and gives the reason as "Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2734-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-24
Posted: 2024-08-27
Recalling firm: Schiller, AG
Product: CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Product code: DPS Electrocardiograph
Reason for recall: Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: UDI-DI: 07613365002775. All serial numbers, all software versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2734-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2734-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-27

Product code DPS

K183425Class IICardiovit at-102 G2Schiller AG / cleared 2020-03-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)