Electrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts
Schiller is recalling CARDIOVIT AT-180 electrocardiographs due to potential high-frequency signal artifacts during ECG acquisition that may affect diagnostic accuracy. 1,084 units are affected worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves potential signal artifacts that could affect ECG diagnostic accuracy. No illnesses or injuries have been reported. Per the rubric, Class II recalls without reported harm are scored as High (3).
Plain-English summary
The CARDIOVIT AT-180 electrocardiograph is a medical device used to record heart electrical activity. Schiller is recalling all affected units (model 0A.110000, catalog 3.920570) due to potential high-frequency signal artifacts during ECG acquisition.
These artifacts may compromise the accuracy of diagnostic readings, potentially affecting the clinical utility of ECG results.
1,084 units have been distributed worldwide, including the United States (Florida) and numerous countries in Europe, Asia, the Middle East, Africa, and Oceania. All serial numbers and software versions are affected (UDI-DI: 07613365002775).
Healthcare facilities using affected devices should contact Schiller, Ag for remediation instructions. Facilities should verify whether their CARDIOVIT AT-180 units are included in this recall.
The recalled product
- Product
- CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
- Manufacturer
- Schiller, Ag
- Affected units
- 1,084
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 07613365002775. All serial numbers
- all software versions.
Distribution
Distributed in 1 state:
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