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U.S. Department of Health and Human Services

Class 2 Device Recall Laryngeal Strobe

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  Class 2 Device Recall Laryngeal Strobe 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-2744-2017
Recall Event ID 77137
Product Classification Transformer, endoscope - Product Code GCW
Product 9400
Laryngeal Strobe

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 35865-10 35866-22 37879-10 38332-20 38935-159 40356-06 41305-16 41687-20 80002-01 80002-17 80279-12 
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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