Z-1492-2021 Class III Terminated
FDA device recall Z-1492-2021 was initiated by Boston Scientific Corporation on March 16, 2021 and is designated Class III. Reason for recall: May have been programmed with a less than optimal brightness setting resulting in a darker than desired image The recall status is terminated (terminated May 2, 2022). Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 5, 2021
- Initiation Date
- March 16, 2021
- Termination Date
- May 2, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
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
Distribution Pattern
US Nationwide distribution in the states of CA, FL, NJ.
Code Information
Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901