Integrated Medical Systems Inc recalls Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

Recall date

January 20, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0897-2016

FDA classification

Class II

Brand / firm

Integrated Medical Systems Inc

Sold / distributed

Distributed US (nationwide) and in Australia.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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