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 |
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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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