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Pentax Medical Company recalls Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and
Recalled August 3, 2016 · FDA recall Z-2279-2016 · Pentax Medical
Hazard
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States. · FDA Class II
Units
819 units
Sold at
US Nationwide Distribution
Description
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Product
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement 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 →