[Recalled] Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforat
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium. |
|---|---|
| Brand / manufacturer | Bien-Air Surgery Sa |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0177-2021 |
| Country of notice | Switzerland |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 September 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The magnet located inside the foot pedal may come off and may result in unattended start of unstoppable motor.
This Class II recall concerns device products distributed in Switzerland 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 Bien-Air Surgery Sa
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.