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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Medical Video Upper GI Scopes

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 Class 2 Device Recall Pentax Medical Video Upper GI Scopessee related information
Date Initiated by FirmJuly 14, 2021
Create DateSeptember 10, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2449-2021
Recall Event ID 88440
510(K)NumberK131855 K181084 K210485 
Product Classification Colonoscope and accessories, flexible/rigid - Product Code FDF
ProductGastroscope 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
Code Information All devices distributed by Pentax in the US between April 2014 and May 2021
FEI Number 1000080301
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact
973-628-2199
Manufacturer 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 2		Device Design
ActionPentax 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
Quantity in Commerce28849 units Total
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FDF
510(K)s with Product Code = FDF
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