Summary
The FDA issued a Class II for CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 by Schiller, Ag. Reason: Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs..
Details
Source
Device Recall
External ID
Z-2734-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
Lot/Code Info: UDI-DI: 07613365002775. All serial numbers, all software versions.
Quantity Affected: 1084 untis
Reason for Recall
Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-24
Company
Baar
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Schiller, Ag has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Schiller, Ag) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Schiller, Ag have FDA actions?
Schiller, Ag has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2734-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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