Reported Jan 31, 2024 · Ongoing
Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It…
Sedecal Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SEDECAL SA · PELAYA, 9 POL. · Algete, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- All serial numbers, UDI-DI 08436046002500.
- Amount recalled
- 845 units
Where it was sold
Why it was recalled
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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