Recall Z-2076-2016— Pentax Medical Company

Name: FDA recall Z-2076-2016
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 3 FDA 510(k) clearances: K131028, K023376, K951199. Product: Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement 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

3 on FDA's record

K131028 — PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)Pentax Medical Company·cleared 2014-04-10
K023376 — EB-1830T3, VIDEO BRONCHOSCOPEPentax Precision Instrument Corp.·cleared 2002-10-16
K951199 — FB-18X, FIBER BRONCHOSCOPEPentax Precision Instrument Corp.·cleared 1995-04-10

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

Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement 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.