—#186375

Product

EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430

FDA product code: FDT — Duodenoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901

Why it was recalled

May have been programmed with a less than optimal brightness setting resulting in a darker than desired image

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, FL, NJ.

Timeline

Recall initiated: 2021-03-16
Terminated: 2022-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186375. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.