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.
- Company
- Pentax Of America Inc
- Recall Initiated
- May 31, 2016
- Terminated
- December 21, 2017
- Recall Number
- Z-2875-2016
- Quantity
- 1719 units
- Firm Location
- Montvale, NJ
Reason for Recall
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Distribution
Nationwide Distribution
Lot / Code Info
EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K
Root Cause
Packaging process control
Action Taken
Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex. Customers with questions were instructed to call 800-431-5880, ext. 2064.
More recalls by Pentax Of America Inc
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monito...
Feb 26, 2025
PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor...
Feb 26, 2025