Recall Z-0820-2012 ยท EOX Esophagoscope (Flexible Or Rigid)
Pentax Medical Company
EE- Series Video Naso Pharyngo Laryngo Scope, VNL-1570STK. Intended to provide optical visualization (via a video monitor) of the Upper Airway.
| Date | Jan 20, 2012 (initiated Sep 30, 2011) |
| Status | Terminated |
| Reason | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. |
| Root cause | Employee error |
| Action | Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary. |
| Quantity | one unit |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.