Date Initiated by Firm |
May 31, 2016 |
Create Date |
September 22, 2016 |
Recall Status1 |
Terminated 3 on December 21, 2017 |
Recall Number |
Z-2875-2016 |
Recall Event ID |
74954 |
510(K)Number |
K131028
|
Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
|
Product |
Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. |
Code Information |
EB-1170K; EB-1570K; EB-1575K; EB=1970K; EB-1970TK; EB-1975K |
Recalling Firm/ Manufacturer |
Pentax of America Inc 3 Paragon Dr Montvale NJ 07645-1782
|
For Additional Information Contact |
Mr. Paul Silva 973-628-2199
|
Manufacturer Reason for Recall |
Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Pentax Medical sent a U.S. Urgent Field Correction notice to all affected customers with a recall letter/return response form on May 31, 2016 via Fed Ex.
Customers with questions were instructed to call 800-431-5880, ext. 2064. |
Quantity in Commerce |
1719 units |
Distribution |
Nationwide Distribution |
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.
|
510(K) Database |
510(K)s with Product Code = EOQ and Original Applicant = PENTAX MEDICAL COMPANY
|