Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointest
FDA device recall Z-2275-2016 · posted 2016-07-23 · Terminated
Recall details
- Recalling firm
- Pentax Medical Company
- Reason for recall
- Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
- Action taken
- Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.com.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FDF
- Quantity affected
- 12,412 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-04-06
- Date posted
- 2016-07-23
- Date terminated
- 2017-07-17
- 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 |
|---|---|---|
| EC-3800L, VIDEO COLONOSCOPE (K951574) | Pentax Precision Instrument Corp. | 1996-03-21 |