FDA Enforcement
Class III
Terminated
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Recall: Z-1492-2021
·
Reported May 5, 2021
Enforcement
- Recall Number
- Z-1492-2021
- Event ID
- 87593
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 5, 2021
- Initiation Date
- March 16, 2021
- Classification Date
- April 26, 2021
- Termination Date
- May 2, 2022
- Address
- 100 Boston Scientific Way, N/A, Marlborough, MA, 01752-1234, United States
Description
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Reason
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Code Info
Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901
Distribution
US Nationwide distribution in the states of CA, FL, NJ.
Quantity
3 units