Integrated Medical Systems Inc recalls Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Recalled March 2, 2016 · FDA recall Z-0908-2016 · Integrated Medical Systems

Hazard

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. · FDA Class II

Units

1 instrument

Sold at

Distributed US (nationwide) and in Australia.

Description

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.

Product

Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

Manufacturer(s)

Integrated Medical Systems Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →