EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualization of (via a video monitor),
FDA device recall Z-0818-2012 · posted 2012-01-20 · Terminated
Recall details
- Recalling firm
- Pentax Medical Company
- Reason for recall
- The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- EOQ
- Quantity affected
- 18 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2011-09-30
- Date posted
- 2012-01-20
- Date terminated
- 2012-11-27
- Location
- Montvale, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EB-1830T3, VIDEO BRONCHOSCOPE (K023376) | Pentax Precision Instrument Corp. | 2002-10-16 |