Recall Z-2449-2021
Pentax of America Inc · initiated July 14, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
Codes / lots: All devices distributed by Pentax in the US between April 2014 and May 2021
Reason for recall
Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
FDA-determined cause: Device Design
Action taken
Pentax issued Urgent Medical Device Correction letter via UPS mailing on 7/14/21. Letter states reason for recall, health risk and action to take (USB drive along with the enclosed instruction sheet enclosed). Letter states: PENTAX separated the EC and EG rIFUs into 5 separate rIFUs . The grouping will allow the following for reprocessing personnel: " Eliminate the need to identify optional configurations of instrument channels and water jet channels " Simplify the instructions and graphics in the individual rIFUs Please replace any previous versions of rIFUs with the most current revision. Please note that this documentation set is current as of this date. For future updates, please refer to the PENTAX online IFU library at https://ifu.pentaxmedical.com. Customer Instructions: Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX at customeradvisories@pentaxmedical.com. Questions regarding this action, please feel free to contact us at: o Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) o Fax: 201-799-4063 (alternate 201-391-4189) o Email: customeradvisories@pentaxmedical.com
Details
- Recall number
- Z-2449-2021
- Initiated
- July 14, 2021
- Product code
- FDF – Colonoscope And Accessories, Flexible/Rigid
- Quantity
- 28849 units Total
- Distribution
- Nationwide
- Recalling firm
- Pentax of America Inc, Montvale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2448-2021 Class II | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel…Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and… | 07/14/2021Open, Classified |