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

Recalled September 28, 2016 · FDA recall Z-2875-2016 · Pentax of America

Hazard

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

Units

1719 units

Sold at

Nationwide Distribution

Description

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

Product

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.

Manufacturer(s)

Pentax of America Inc

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