Recall Z-1327-2019 — Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s
U.S. FDA — Device Enforcement · United States · 2018-12-03 · Class II
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Reported risk: Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
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