CardioTek EP-TRACER Software V2.x.
FDA Recall Z-1283-2022 · Posted None
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Recalling FirmCardioTek BV
Recall StatusCompleted
Product CodeDQK
Date Initiated2022-04-25
Product Quantity146 units
Reason for Recall
Device did not pass electrical safety testing for adequate insulation.
Firm Action
The firm issued a recall notification to consignees on 04/25/2022 via email. On 05/24/2022 the firm sent an updated field safety notice. The consignee can continue to use the device. The firm will contact the customer to schedule an appointment for the rework. The consignee is to pass on the letter to those that need to be made aware of the notice.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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