Date Initiated by Firm |
April 13, 2017 |
Create Date |
July 18, 2017 |
Recall Status1 |
Terminated 3 on March 22, 2019 |
Recall Number |
Z-2742-2017 |
Recall Event ID |
77137 |
Product Classification |
Transformer, endoscope - Product Code GCW
|
Product |
7245C, 7245C/E, 7245D Computer Digital Video System
Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications.
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Code Information |
24966-06 25281-01 26060-10 26874-03 26874-06 28669-04 28671-02 28671-04 28675-04 30150-02 30150-03 30604-09 31525-03 31525-09 31526-19 32945-04 36453-10 36453-13 38476-04 38476-07 38748-101 38976-04 39444-02 39471-09 39508-151 41735-05 41735-08 41735-11 45810-14 47969-04 80397-09 80400-01 80850-02 25631-07 27406.05 28677-10 30737-12 34599-04 37836-05 4124-07 45735-03 45810-08 80910-02 |
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
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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.
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