Algete, N/A, Spain
Sedecal S.A. recalls
1 recall recorded since 2018, most recently on 18 July 2018. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 July 2018
- Reason
- 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.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0488-2019
- Sedecal NOVA FA DR System. for diagnostic radiography.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.