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Pentax Medical Video Colonoscope, Pentax Medical Video Processor, Pentax Medi...

# Major Recall Alert: Pentax Medical Endoscopic Devices Recalled Due to Overheating and Potential Mucosal Injuries

Pentax Medical has announced a critical recall for its **Pentax Medical Video Colonoscope**, **Pentax Medical Video Processor**, and **Pentax Medical Video Upper GI Scope (EG29-I20C)**. The issue arises under certain conditions during endoscopic procedures, where the **image observed may become reddish or dark**, and the **light guide at the tip of the scope may overheat**, leading to potential thermal injuries to the patient’s mucosal membranes.

This recall impacts a combination of the **Pentax Medical Video Processor (EPK-I8020C)** and the **Pentax Medical Video Upper GI Scope (EG29-I20C)**, with **32 global complaints** reported. The recall officially begins on **February 18, 2025**. Here’s a full breakdown of this safety concern and what steps you should take to stay informed.

## Why This Recall is Important

This recall highlights a significant safety threat associated with **Pentax Medical’s endoscopic devices** used in upper gastrointestinal procedures.

### Key Concerns:
- **Overheating and Potential Burns**
The **light guide** at the distal end of the scope can **overheat**, particularly in the presence of blood or mucus that absorbs the illumination light. Patients are at risk of **thermal injuries** to their mucous membranes.

- **Image Quality Issues**
During procedures, users reported that the observed image could appear **reddish or dark**, which may compromise the visibility required for accurate diagnosis or treatment.

- **Smoke-Like Steam Emission**
Some complaints noted the presence of **smoke-like steam** during or after use, causing additional concerns for patient safety and equipment reliability.

Although the **instructions for use** already include cautionary guidance for similar risks, this recall emphasizes the urgency of reviewing device usage to prevent harm.

## Details of the Recall

Pentax Medical devices affected by this recall include:

- **Pentax Medical Video Colonoscope**
- **Pentax Medical Video Processor (EPK-I8020C)**
- **Pentax Medical Video Upper GI Scope (EG29-I20C)**

### Reported Safety Concerns:
- **32 complaints globally** related to overheating and equipment malfunction.
- Complaints were associated with both **white light** and **OE (Optical Enhancement) mode**, although risks are higher in OE mode.
- **Potential for patient thermal injuries** due to overheating when substances like mucus or blood attach to the light guide during procedures.

### Start Date of Recall:
**February 18, 2025**

This recall aims to reduce the risk of harm and ensure healthcare professionals follow robust safety protocols.

## What You Should Do

If you’re a healthcare professional or user of Pentax Medical endoscopic devices, take the following steps immediately:

- **Review the Manufacturer Communication**
Pentax Medical has issued explicit safety guidelines and updates associated with affected devices. Access the official recall notice here: [Pentax Medical Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/pentax-medical-video-processors).

- **Follow the Updated Instructions for Use**
Verify that all staff and technicians are aware of the risks, particularly when using **OE mode**. Avoiding excessive exposure to impacted light guides can mitigate overheating risks.

- **Monitor for Signs of Failure**
Be vigilant for reddish or dark images, overheating at the device tip, and smoke-like steam. Discontinue device use if these symptoms occur.

- **Contact Pentax Medical**
Reach out to the company’s support team for assistance, replacement, or further instruction regarding recalled devices.

## Stay Safe – Get Instant Recall Alerts

Device recalls like this emphasize the importance of staying updated on the latest safety communications. Protect yourself and your patients by subscribing to real-time recall alerts directly from trusted authorities.

### Download the App for Instant Updates!

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For more details on this recall, visit the official recall page: [Pentax Medical Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/pentax-medical-video-processors).

Stay informed, follow the guidelines, and prioritize patient safety during endoscopic procedures.

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