Date Initiated by Firm |
April 13, 2017 |
Create Date |
July 18, 2017 |
Recall Status1 |
Terminated 3 on March 22, 2019 |
Recall Number |
Z-2745-2017 |
Recall Event ID |
77137 |
Product Classification |
Transformer, endoscope - Product Code GCW
|
Product |
9200C and 9200D 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 |
40552 22679-05 23546-06 23546-07 24036-06 24045-03 24045-06 24045-08 24045-09 24049-01 24049-03 24049-08 24231-10 24556-01 24556-06 24965-07 25282-03 25351-06 25459-01 25459-07 25459-08 25459-09 25461-01 25461-03 25461-05 25461-07 25461-09 25466-07 25466-08 25964-01 25964-03 25964-11 25965-02 25965-05 25965-12 26035-13 26055-02 26055-13 26055-18 26056-04 26056-05 26056-08 26057-03 26057-18 26058-18 26058-20 26870-09 26871-02 26871-02 26871-03 26871-03 26871-07 26871-11 26871-12 26871-14 26871-17 26871-18 26872-05 26872-06 26872-08 26872-10 26872-16 26872-18 26872-18 26872-20 26873-10 26873-16 26873-20 28073-02 28668-11 28670-03 28670-07 28670-12 28670-14 28672-14 28672-18 28674-03 28674-17 28676-08 29880-09 30001-02 30598-04 30598-09 30598-21 30599-04 30599-06 30599-13 30600-02 30600-03 30600-06 30601-11 30601-14 31523-07 31523-15 31523-21 31524-01 33226 33226-05 33226-06 33226-16 33413-05 33413-10 34162-07 34162-09 34162-20 34593-07 35263-06 35263-10 36135-14 36315-02 36315-13 36315-19 36600-13 36890-11 36890-12 36890-19 37419-13 37835-15 38524-09 38776-05 38850-01 38850-04 38850-06 39951-05 39952-024 39952-03 39952-04 41241-10 41577-09 41577-19 41577-20 41577-21 41861-14 41861-15 41861-16 42024-08 441046-01 45770-03 94965-03 48029-01 48029-06 |
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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