[Recalled] EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 — May have been programmed with a less than optimal brightness sett
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 |
|---|---|
| Brand / manufacturer | Boston Scientific Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1492-2021 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 16 March 2021 |
| EAN / barcode | 2005201213 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Boston Scientific Corporation
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.