FDA Recall
Terminated
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.
Recall: Z-2875-2016
·
Initiated May 31, 2016
Recall
- Recall Number
- Z-2875-2016
- Event Number
- 74954
- Firm
- Pentax of America Inc
- FEI Number
- 1000080301
- Product Code
- EOQ
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- May 31, 2016
- Terminated
- December 21, 2017
- Address
- 3 Paragon Dr, Montvale, NJ, 07645-1782
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
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
Action
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.
Distribution
Nationwide Distribution
Quantity
1719 units