CardioTek BV Recalls
2 recalls on record · July 12, 2017 to June 29, 2022 · Medical Devices
Recalls by year
17
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 29, 2022Medical DevicesFDA
CardioTek BV recalls CardioTek EP-TRACER Software V2.x.
Hazard: Device did not pass electrical safety testing for adequate insulation.
July 12, 2017Medical DevicesFDA
CardioTek BV recalls CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to ac
Hazard: Software bug which allows parameters to be changed unintentionally during use.