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Pentax of America Inc recalls Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualizati
Recalled December 21, 2016 · FDA recall Z-0757-2017 · Pentax of America
Hazard
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. · FDA Class II
Units
113 units
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Pentax of America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →