Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation eq
FDA device recall Z-0636-2017 · posted 2016-11-19 · Terminated
Recall details
- Recalling firm
- Pentax of America Inc
- Reason for recall
- Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
- Action taken
- Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- FDF
- Quantity affected
- 5,090 (US) and 14,209 (OUS)
- Distribution
- US Nationwide and Japan
- Date initiated
- 2016-08-15
- Date posted
- 2016-11-19
- Date terminated
- 2018-03-08
- Location
- Montvale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PENTAX VIDEO COLONOSCOPES (EC FAMILY) (K131855) | Pentax Medical Company | 2014-04-09 |