Recall Z-2875-2016— Pentax of America Inc

Name: FDA recall Z-2875-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-31

Class II · Terminated

Class II FDA medical device recall by Pentax of America Inc, initiated 2016-05-31, terminated 2017-12-21. It names one FDA 510(k) clearance: K131028. Product: Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.. Reason: Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS..

Recalling firm: Pentax of America Inc
Classification: Class II
Status: Terminated
Initiated: 2016-05-31
Terminated: 2017-12-21
Firm location: Montvale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K131028 — PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)Pentax Medical Company·cleared 2014-04-10

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

Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

Reason for recall

Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.

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