Date Initiated by Firm |
August 15, 2016 |
Date Posted |
November 19, 2016 |
Recall Status1 |
Terminated 3 on March 08, 2018 |
Recall Number |
Z-0636-2017 |
Recall Event ID |
75306 |
510(K)Number |
K131855
|
Product Classification |
Colonoscope and accessories, flexible/rigid - Product Code FDF
|
Product |
Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. |
Code Information |
Model #'s EC-2990LI, EC-3490LI, EC-3490LK, EC-3490TLI, EC-3890LI, EC-3890LK and EC-3890TLK |
Recalling Firm/ Manufacturer |
Pentax of America Inc 3 Paragon Dr Montvale NJ 07645-1782
|
For Additional Information Contact |
Mr. Paul Silva 800-431-5880 Ext. 2064
|
Manufacturer 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).
|
FDA Determined Cause 2 |
Other |
Action |
Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers. |
Quantity in Commerce |
5,090 (US) and 14,209 (OUS) |
Distribution |
US Nationwide and Japan |
Total Product Life Cycle |
TPLC Device Report
|
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FDF and Original Applicant = PENTAX MEDICAL COMPANY
|