Recall Z-2875-2016 ยท EOQ Bronchoscope (Flexible Or Rigid)
Pentax of America Inc
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.
| Date | May 31, 2016 |
| Status | Terminated |
| Reason | Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS. |
| Root cause | Packaging process control |
| 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. |
| Quantity | 1719 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131028 | PENTAX VIDEO BRONCHOSCOPES (EB FAMILY) Pentax Medical Company, Apr 10, 2014 |