SEDEC: Sedecal X Optima URS digital mobile diagnostic x-ray system with falling parts poses safety risk to patients and users. Recall details and action steps provided.
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
SEDECAL's Sedecal X Optima URS digital mobile x-ray system has been recalled because some parts have fallen off, creating a safety risk for patients and users. This could lead to injuries if the equipment is not properly secured.
The x-ray system has parts that can detach, potentially causing injuries to patients or users. This risk occurs when the equipment is not securely mounted or maintained.
Healthcare facilities using the Sedecal X Optima URS x-ray system are most at risk. Patients and staff during x-ray procedures may be affected if parts fall.
The Sedecal X Optima URS digital mobile diagnostic x-ray system with serial numbers starting with 08436046002500 is affected. This model has a universal swivel arm for mobile x-ray use.
Ensure the x-ray system is securely mounted and not loose before use.
This recall applies to Sedecal X Optima URS digital mobile diagnostic x-ray systems with serial numbers starting with 08436046002500.
The official recall does not specify actions for parts that have already fallen off. Contact SEDECAL SA for guidance.
Look for serial numbers starting with 08436046002500 on the Sedecal X Optima URS system.
We’ve drafted a message you can send SEDECAL to request your refund or repair — edit it as you like.
Subject: Recall Z-0781-2024 — SEDECAL SEDECAL Hello, I own a SEDECAL that is covered by recall Z-0781-2024 from SEDECAL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
