Recall Z-1492-2021 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Boston Scientific Corporation
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
| Date | Mar 16, 2021 |
| Status | Terminated |
| Reason | May have been programmed with a less than optimal brightness setting resulting in a darker than desired image |
| Root cause | 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 t |
| Quantity | 3 units |
| Distribution | US Nationwide distribution in the states of CA, FL, NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.