Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation eq
FDA device recall Z-0318-2017 · posted 2016-10-26 · Terminated
Recall details
- Recalling firm
- Pentax of America Inc
- Reason for recall
- PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
- Action taken
- Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FDS
- Quantity affected
- 3,436 (US) and 14,488 (OUS)
- Distribution
- US Nationwide and Japan
- Date initiated
- 2016-08-15
- Date posted
- 2016-10-26
- Date terminated
- 2019-04-23
- Location
- Montvale, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) (K131902) | Pentax Medical Company | 2014-04-10 |