FDA Device recall Z-0781-2024
Sedecal X Optima URS digital mobile diagnostic x-ray system
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Sedecal X Optima URS digital mobile diagnostic x-ray system by Sedecal, citing some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0781-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-13 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Sedecal |
| Distribution | AL, FL, NC |
Product
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
Reason
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Identifiers
| code_info | All serial numbers, UDI-DI 08436046002500. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0781-2024%22
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