Device Recall 1500T14 Cardiac Ablation System Generator
Modèle / numéro de série
Serial Number 13637656, 13614863, 13614862.
Distribution
International distribution only: Canada and Japan.
Description du dispositif
1500T14 Cardiac Ablation System - Generator || The 1500Tl4 Cardiac Ablation System operates in conjunction with a commercially available external Disposable Indifferent (Dispersive) Patch (DIP) electrode. The catheter delivers RF power in a monopolar mode between its distal electrode and the DIP electrode. The Generator incorporates a medical grade power supply. This power supply can be used for various line voltages and frequencies without any modifications. Utilizing microprocessor control, the Generator produces a continuous nonmodulated radio frequency (RF) output at 485 KHz. Its front panel displays the command power output, tissue impedance, and tissue temperature. The Generator measures root-mean-square (RMS) voltage, RMS current, and command power output by taking the average value of the product of voltage and current. This reflects the effective heating power delivered to the tissue from the catheter large electrode (tip electrode or other ablating electrodes). Impedance is calculated as RMS voltage divided by RMS current. The amount and duration of RF power delivery is user- selectable. The Generator has four (4) independent channels for monitoring the tissue temperature simultaneously using thermocouple sensor and i-channel (thermistor) for catheters using a thermistor sensor. The desired temperature is user-selectable when busing a catheter with a temperature sensor. If using a catheter with a temperature sensor, the output power of the Generator will shut off if the measured temperature exceeds 80¿C or if the measured temperature exceeds the user-selected temperature set point by more than 5¿C for greater than 3 seconds. If using a catheter with 4 temperature sensors, the output power of the Generator will shut off when the highest temperature detected from anyone of the temperature sensors is exceeds the preset temperature by more than 5¿C for greater than 3 seconds or exceeding 80¿C.The Generator has built-in safety features which include automatic RF power shutoff if the measured tissue impedance falls below 50 ohms or exceeds 300 ohms or the preset impedance value.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.