Sedecal X Optima URS digital mobile diagnostic x-ray recall
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…
Why was Sedecal X Optima URS digital mobile diagnostic x-ray recalled?
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All serial numbers, UDI-DI 08436046002500.
- 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…
- Recalling firm
- SEDECAL SA
- Quantity
- 845 units
- Distribution
- Distribution was made to AL, FL, and NC. There was no military/government distribution.
- Recall date
- January 31, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)