Recall Z-1492-2021— Boston Scientific Corporation
Class III · Terminated
Class III FDA medical device recall by Boston Scientific Corporation, initiated 2021-03-16, terminated 2022-05-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2021-03-16
- Terminated
- 2022-05-02
- Firm location
- Marlborough, MA, United States
Product description
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430
Reason for recall
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Data sourced from openFDA. This site is unofficial and independent of the FDA.