Recall Z-2276-2016— Pentax Medical Company

Name: FDA recall Z-2276-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-06

Class II · Terminated

Class II FDA medical device recall by Pentax Medical Company, initiated 2016-04-06, terminated 2017-07-17. It names one FDA 510(k) clearance: K042741. Product: Confocal GI Scope 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.. Reason: 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..

Recalling firm: Pentax Medical Company
Classification: Class II
Status: Terminated
Initiated: 2016-04-06
Terminated: 2017-07-17
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K042741 — EC-3870CILK, CONFOCAL VIDEO COLONOSCOPEPentax Medical Company·cleared 2004-10-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Confocal GI Scope 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.