Device product
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Z-1492-2021
Product summary
- Event
- Event 87593
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-1492-2021
Official wording
Reason: May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Code information: Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
Distribution pattern: US Nationwide distribution in the states of CA, FL, NJ.
Derived failure modes
-
Unknown
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image