[Recalled] Sedecal NOVA FA DR System. for diagnostic radiography. — A safety problem with installation and maintenance could lead to the breakage o… | FDA 2018-07-18
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Sedecal NOVA FA DR System. for diagnostic radiography. |
|---|---|
| Brand / manufacturer | Sedecal S.A. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0488-2019 |
| Country of notice | Spain |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 18 July 2018 |
| EAN / barcode | 07360816 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
This Class II recall concerns device products distributed in Spain 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 Sedecal S.A.
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.