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.
Reported: January 31, 2024 Initiated: December 13, 2023 #Z-0781-2024
Product Description
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 for Recall
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Details
- Recalling Firm
- SEDECAL SA
- Units Affected
- 845 units
- Distribution
- Distribution was made to AL, FL, and NC. There was no military/government distribution.
- Location
- Algete, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by SEDECAL SA. Units affected: 845 units.
Why was this product recalled? ▼
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 31, 2024. Severity: Moderate. Recall number: Z-0781-2024.
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