The Recall Desk
HighFDA (Devices)·Z-0909-2016·Announced 2016-03-02

Olympus CF-Q140L Video Colonoscope Recalled for Internal Coil Detachment

Integrated Medical Systems Inc is recalling two Olympus CF-Q140L video colonoscopes because excessive pressure can cause the internal coil pipe assembly to detach.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where the defect could lead to improper operation during a procedure, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Integrated Medical Systems Inc is recalling two Olympus Model No. CF-Q140L flexible video colonoscopes. The recall is due to a defect where excessive pressure applied to the distal end of the endoscope can cause the internal coil pipe assembly to become detached. When this occurs, the angulation of the scope may not operate as intended.

The affected instruments have serial numbers 2913081 and 2600279. These devices were distributed nationwide in the United States and in Australia.

Healthcare facilities should stop using the affected instruments and contact Integrated Medical Systems Inc for instructions on how to proceed.

The recalled product

Product
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Serial Numbers: 2913081
  • 2600279

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 22 recalled by Integrated Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 22 products in this recall →