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U.S. Department of Health and Human Services

Class 2 Device Recall Digital Video Capture Modules

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  Class 2 Device Recall Digital Video Capture Modules see related information
Date Initiated by Firm April 13, 2017
Create Date July 18, 2017
Recall Status1 Terminated 3 on March 22, 2019
Recall Number Z-2743-2017
Recall Event ID 77137
Product Classification Transformer, endoscope - Product Code GCW
Product 9310HD
Digital Video Capture Modules

Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
Code Information 80847 38953-09 40156-01 40156-09 40158-15 40669-02 40669-09 40670-05 42094-05 45852-06 46800-05 47452-01 48653-02 48653-03 49242-02 72872-49A 80361-14 80362-01 80362-02 80365-05 80399-05 80399-09 80481-07 80841-02 80842-05 80847-06 80878-07 80879-06 80879-08 80880-01 80881-05 80883-03 80884-03 80886-06 80886-11 80886-13 80887-02 80887-08 
Recalling Firm/
Manufacturer		 Pentax of America Inc
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact
800-431-5880
Manufacturer Reason
for Recall		 Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems.
FDA Determined
Cause 2		 Device Design
Action Pentax notified their customers on 4/13/2017 via USPS.
Quantity in Commerce 241 units in total
Distribution Worldwide Distribution - US Nationwide
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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