CLASS II ONGOING Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
Cardiovit recalled by Schiller, Ag
Schiller is recalling Cardiovit At-180, distributed in Florida. The recall was initiated on 24 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2734-2024
- FDA event ID
- 95074
- Recalling firm
- Schiller, Baar
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2024
- FDA classified
- 27 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Jul 2024 | Recall initiated by company | |
| 27 Aug 2024 | Classified by FDA | +34 days |
| 4 Sep 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
Product as listed by the FDA
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
Which lots are affected?
UDI-DI: 07613365002775. All serial numbers, all software versions.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Schiller
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Argus PB-3000, Reference Numbers: 1A.701307 recalled by Schiller, Ag | Schiller | Other | Nationwide |
Other Other Medical Devices recalls
All 13,929| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
| Device | CLASS II | NeuroStar Advanced Therapy System recalled by Neuronetics | Neuronetics | Other | Nationwide |
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |