Pentax of America Inc recalls Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualizatio…

Recall date

May 31, 2016

Source

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

Recall number

Z-0757-2017

FDA classification

Class II

Brand / firm

Pentax of America Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared 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

Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.