FDA Device recall Z-0488-2019
Sedecal NOVA FA DR System. for diagnostic radiography
- FDA Device
- Class II
- ongoing
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of Sedecal NOVA FA DR System. for diagnostic radiography by Sedecal, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0488-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-07-18 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Sedecal |
| Distribution | n/a |
Product
Sedecal NOVA FA DR System. for diagnostic radiography.
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.
Identifiers
| code_info | Serial Numbers 07360816 through 17291024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0488-2019%22
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