Date Initiated by Firm | June 30, 2015 |
Date Posted | September 17, 2015 |
Recall Status1 |
Terminated 3 on May 25, 2017 |
Recall Number | Z-2778-2015 |
Recall Event ID |
71695 |
510(K)Number | K042076 K944620 |
Product Classification |
duodenoscope and accessories, flexible/rigid - Product Code FDT
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Product | Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. |
Code Information |
ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681 |
Recalling Firm/ Manufacturer |
Fujifilm Medical Systems U.S.A., Inc. 10 Highpoint Dr Wayne NJ 07470-7431
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For Additional Information Contact | Ms. Sarah Contreras 973-709-2202 |
Manufacturer Reason for Recall | The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures. |
FDA Determined Cause 2 | Device Design |
Action | FujiFilm sent a Voluntary Field Correction/Verification Form dated June 30, 2015 to their affected customers. |
Quantity in Commerce | 256 units |
Distribution | Distributed in the US and Canada. |
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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510(K) Database | 510(K)s with Product Code = FDT 510(K)s with Product Code = FDT
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