[Recalled] Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope — If excessive pressure is applied to the distal end of the endoscope, the intern… | FDA 2016-01-20
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope |
|---|---|
| Brand / manufacturer | Integrated Medical Systems Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0907-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 20 January 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Integrated Medical Systems Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.