Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This
FDA device recall Z-2069-2016 · posted 2016-06-28 · Terminated
Recall details
- Recalling firm
- Pentax Medical Company
- Reason for recall
- Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
- Action taken
- Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 17 units
- Distribution
- Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
- Date initiated
- 2016-04-06
- Date posted
- 2016-06-28
- Date terminated
- 2017-12-21
- Location
- Montvale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE (K042741) | Pentax Medical Company | 2004-10-19 |