Pentax C2 CryoBalloon Controller Recalled for Overpressure Detection Failure
Pentax of America Inc is recalling 45 C2 CryoBalloon Controllers because the device fails to detect balloon overpressure during specific nitrous oxide applications, posing a risk of patient injury.
- Product
- C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 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 Esopha
- Category
- Medical Device
- Distribution
- Distributed nationwide