Recall Z-2734-2024— Schiller, Ag

Name: FDA recall Z-2734-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-24

Class II · Ongoing

Class II FDA medical device recall by Schiller, Ag, initiated 2024-07-24. It names one FDA 510(k) clearance: K183425. Product: CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570. Reason: Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs..

Recalling firm: Schiller, Ag
Classification: Class II
Status: Ongoing
Initiated: 2024-07-24
Firm location: Baar, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K183425 — CARDIOVIT AT-102 G2Schiller AG·cleared 2020-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

Data sourced from openFDA. This site is unofficial and independent of the FDA.