Recall Z-2066-2016— Pentax Medical Company

Name: FDA recall Z-2066-2016
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 2017-12-21. It names one FDA 510(k) clearance: K951191. Product: Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.. Reason: Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel..

Recalling firm: Pentax Medical Company
Classification: Class II
Status: Terminated
Initiated: 2016-04-06
Terminated: 2017-12-21
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K951191 — FCN-15X, FIBER CHOLEDOCHONEPHROSCOPEPentax Precision Instrument Corp.·cleared 1995-05-30

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

Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

Reason for recall

Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

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