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U.S. Department of Health and Human Services

Class 3 Device Recall EXALT Controller

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  Class 3 Device Recall EXALT Controller see related information
Date Initiated by Firm March 16, 2021
Create Date April 26, 2021
Recall Status1 Terminated 3 on May 02, 2022
Recall Number Z-1492-2021
Recall Event ID 87593
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
Product EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Code Information Serial Numbers:  2005201213 2005201287  2005201346  GTIN: 08714729990901
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Rebecca KinKead Rubio
651-581-0761
Manufacturer Reason
for Recall		 May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
FDA Determined
Cause 2		 Process control
Action Boston Scientific issued Medical Device Removal - Immediate Action Required letter on 3/16/21. Letter states reason for recall, health risk and action to take: While no adverse health consequences are anticipated and an impacted Controller can continue to be used, replacement of the Controller is advised for optimal image quality. A Boston Scientific representative will be in contact with you directly to schedule installation of a replacement Controller at your facility. If you notice a darker than desired image, manually adjust the brightness setting on the front of the EXALT" Controller to the High setting (all five bars on the Brightness Indicator illuminated) A Boston Scientific representative will be in contact with you directly to schedule the installation of a replacement Controller at your facility. Your current Controller will be removed at that time. Please read carefully through the enclosed instructions. We ask that you please confirm receipt of this notification by completing the enclosed Acknowledgement Form and sending it to BSCFieldActionCenter@bsci.com or fax to 763-415-7708.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of CA, FL, NJ.
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.
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