SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain
Lot Codes / Batch Numbers
All serial numbers, UDI-DI 08436046002500.
Products Sold
All serial numbers, UDI-DI 08436046002500.
SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain is recalling Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a uni due to Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, FL, NC
Page updated: Jan 10, 2026