[Recalled] Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures. — Certain Auriga consoles have incorrectly assembled trigger wire components | FDA 2017-09-22
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures. |
|---|---|
| Brand / manufacturer | Boston Scientific Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0897-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 September 2017 |
| EAN / barcode | 20413941 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console.
This Class II 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.