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Pentax Medical Company recalls Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointesti
Recalled August 3, 2016 · FDA recall Z-2277-2016 · 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
433 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
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed 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 →