Pentax Medical Company recalls Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway

Recalled July 6, 2016 · FDA recall Z-2073-2016 · Pentax Medical

Hazard

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. · FDA Class II

Units

206 units

Sold at

Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

Description

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

Product

Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Manufacturer(s)

Pentax Medical Company

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