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U.S. Department of Health and Human Services

Class 2 Device Recall Pentax Video Bronchoscopes

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  Class 2 Device Recall Pentax Video Bronchoscopes see related information
Date Initiated by Firm September 30, 2011
Date Posted January 20, 2012
Recall Status1 Terminated 3 on November 27, 2012
Recall Number Z-0818-2012
Recall Event ID 60788
510(K)Number K023376  
Product Classification Esophagoscope (flexible or rigid) - Product Code EOQ
Product EB- Series Video Bronchoscopes, EB-1570K & EB-1970K.

Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract.
Code Information 1) EB-1570K   G110999 A110254 I A110067  G110338  G110522  G111115 A110125 A110019  A110277  G110538  G111192  G111270 G111216   G111254 G110973 A110022 G111250  2) EB-1970K A110151
Recalling Firm/
Manufacturer		 Pentax Medical Company
3 Paragon Dr
Montvale NJ 07645-1782
For Additional Information Contact Mr. Paul Silva
201-571-2300
Manufacturer Reason
for Recall		 The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
FDA Determined
Cause 2		 Employee error
Action Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
Quantity in Commerce 18 units
Distribution Nationwide Distribution.
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.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = PENTAX PRECISION INSTRUMENT CORP.
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