Sedecal X Optima URS digital mobile diagnostic x-ray system recallZ-0781-2024 · Sedecal SA · initiated Dec 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sedecal SA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
FDA root cause category: Equipment maintenance
What the company is doing
On 12/13/2023, the recalling firm emailed the recall letter dated 12/11/2023 to their distributor customers along with attachments for service and maintenance of the units. The letter explained a description of the issue and that the installed devices should be inspected to ensure they are being used in a safe mode (the unit has been properly maintained and does not show any signs of the screws loosening) and to fix any potential issues. This inspection will also be included in all scheduled maintenance tasks to be performed in the future. The letter is to be distributed to all staff involved. The letter included 3 attachments. Annex 1 contains further information regarding the issue. Annex 2 is the acknowledgement of receipt of the notification and understanding of the described problem and its importance. Annex 3 is confirmation that the mandatory field checks or upgrade of the affected unit is complete. The firm reported distributors will provide the information to the medical facility either by using the recalling firm's letter or creating a new letter.
Recall details
- Recall number
- Z-0781-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 13, 2023
- Posted by the FDA
- Jan 23, 2024
- Recalling firm
- Sedecal SA
- Quantity
- 845 units
- Product code
- KPR
- FDA submissions
- K012546
- Distribution
- Distribution was made to AL, FL, and NC. There was no military/government distribution.
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.
Code information (models, lots, serial numbers)
All serial numbers, UDI-DI 08436046002500.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SEDECAL SEDECAL X URSSedecal · System, X-Ray, Stationary1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K012546 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SEDECAL SEDECAL X (URS)Sedecal · System, X-Ray, Stationary1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page