Recall Z-1283-2022— CardioTek BV

Name: FDA recall Z-1283-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-25

Class II · Completed

Class II FDA medical device recall by CardioTek BV, initiated 2022-04-25. It names one FDA 510(k) clearance: K183266. Product: CardioTek EP-TRACER Software V2.x.. Reason: Device did not pass electrical safety testing for adequate insulation..

Recalling firm: CardioTek BV
Classification: Class II
Status: Completed
Initiated: 2022-04-25
Firm location: Maastricht-Airport, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K183266 — EP-TRACER SystemSchwarzer Cardiotek GmbH·cleared 2019-03-01

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

CardioTek EP-TRACER Software V2.x.

Reason for recall

Device did not pass electrical safety testing for adequate insulation.

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