SEDECAL SEDECAL X URSRecalls & reported problems
Sedecal · The SEDECAL X URS Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K012546); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Dec 13, 2023Open, Classified
Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
Z-0781-2024 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012546. One submission often covers many models, so check the product and lot details in each record.
- Z-0652-03 · Sep 24, 2002 · TerminatedOptima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN
Other System, X-Ray, Stationary devices
- FDR Visionary Suite 566-16130-23Shimadzu Corporation · System, X-Ray, Stationary4 recalls0 reports
- FDR Visionary Suite 566-16130-31Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- FDR Visionary Suite 566-16130-33Shimadzu Corporation · System, X-Ray, Stationary2 recalls0 reports
- Proteus XRaGE Hualun Medical Systems Co., Ltd · System, x-ray, stationary2 recalls0 reports
- Radiography 7300 C 712037Philips Medical Systems DMC GmbH · System, X-Ray, Stationary1 recall1 death8 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall8 reports
- DigitalDiagnost C50Philips Healthcare (Suzhou) Co., Ltd. · System, x-ray, stationary1 recall5 reports
- DRX-Compass X-ray SystemCarestream Health, Inc. · System, x-ray, stationary1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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