Pentax recalls specific cryosurgical catheters due to potential incorrect dose transmission if RFID tags aren't properly read by controllers. This could affect medical procedures involving endoscopic ablation of Barrett's esophagus.
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.
Pentax is recalling certain cryosurgical catheters that may transmit incorrect dose settings to the controller if the RFID tag isn't properly read. This could lead to improper treatment during endoscopic procedures for Barrett's esophagus.
The catheter's RFID tag may not be correctly read by the controller, causing incorrect dose settings to be transmitted. This could result in improper treatment during endoscopic ablation procedures for Barrett's esophagus.
Medical professionals using the Pentax C2 CryoBalloon Standard 90 degree Catheter (Model FG 1030) for endoscopic ablation procedures. Patients undergoing treatment for Barrett's esophagus are at risk if the catheter is used incorrectly.
Check for the model number FG 1030 on the catheter. The product was sold with lot/serial number 08062018-03. This catheter is used in endoscopic ablation procedures for Barrett's esophagus.
Check the catheter for model number FG 1030 and lot/serial number 08062018-03.
The recall indicates a potential risk with incorrect dose transmission if the RFID tag isn't properly read. The catheter is still safe to use if the RFID tag is correctly read by the controller.
The recall does not specify a remedy, so no action is required unless you notice incorrect dose transmission.
Yes, this catheter is used in endoscopic ablation procedures for Barrett's esophagus.
We’ve drafted a message you can send Pentax to request your refund or repair — edit it as you like.
Subject: Recall Z-1327-2019 — Pentax Pentax Hello, I own a Pentax that is covered by recall Z-1327-2019 from Pentax. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
