Recall Z-0818-2012 ยท EOQ Bronchoscope (Flexible Or Rigid)
Pentax Medical Company
EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract.
| 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 | 18 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023376 | EB-1830T3, VIDEO BRONCHOSCOPE Pentax Precision Instrument Corp., Oct 16, 2002 |