Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Olympus Recalled by Integrated Medical Systems Inc Due to If excessive pressure is applied to the distal...

Date: January 20, 2016
Company: Integrated Medical Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integrated Medical Systems Inc directly.

Affected Products

Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

Quantity: 5 instruments

Why Was This Recalled?

If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integrated Medical Systems Inc

Integrated Medical Systems Inc has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report