Pentax of America Inc recalls Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equ…

Recall date

May 31, 2016

Source

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

Recall number

Z-2875-2016

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

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

What was recalled

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.