FDA Device recall Z-1492-2021
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observ…
- FDA Device
- Class III
- terminated
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class III recall of EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observ… by Boston Scientific, citing may have been programmed with a less than optimal brightness setting resulting in a darker than desired image.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1492-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-03-16 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
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
Identifiers
| code_info | Serial Numbers: 2005201213 2005201287 2005201346 GTIN: 08714729990901 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1492-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.