SEDECAL SEDECAL X (URS)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08436046000933), received between Jun 5, 2022 and Jun 5, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 5, 2022Material Separation; Material Separation

  THIS IS A DIAGNOSTIC STATIONARY X-RAY SYSTEM WITH A DIGITAL X-RAY RECEPTOR PANEL. THE WHOLE TUBE ARM ASSEMBLY FELL OFF STRAIGHT ARM. TECHNOLOGIST BROUGHT PATIENT INTO ROOM TO DO A CHEST STUDY AND MOVED STRAIGHT ARM INTO FIRST POSITION FOR CHEST STUDY AND STATED THE ENTIRE TUBE ARM FELL OFF HITTING THE TECHNOLOGIST HAND AND WRIST AND THEN FALLING TO THE GROUND. THE PATIENT WAS NOT NEAR TUBESTAND AT THE TIME OF INCIDENT SO PATIENT DID NOT GET INJURED. INJURY: TECHNOLOGIST HAD CONTUSIONS ON HER RIGHT HAND AND WRIST AND WAS TREATED AT THE FACILITY FOR HER INJURY AND THEN SENT HOME. WE SHOULD STATE THAT HIS UNIT HAS BEEN WORKING IN THE FIELD FOR 9 YEARS. IF THOSE 8 SCREWS ARE PARTIALLY LOOSENED THE PLAY AND NOISE COMING FROM THE ARM WHEN IT IS BEING MOVED SHOULD BE EVIDENT FOR THE TECHNOLOGIST MUCH EARLIER THAN HAVING FALLING RISK, BUT THE UNIT, IN THIS DEFICIENT STATE, CONTINUED IN USE TILL THE ARM FELL DOWN. THE CAUSE OF THIS EVENT IS IMPROPER MAINTENANCE. THE MANUFACTURER IS CONSIDERING ACTIONS FOR THE INSTALLED BASE.

  Patient problems: Bruise/Contusion

  MAUDE report 14599441 ↗

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-0781-2024 · Dec 13, 2023 · Open, Classified
  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, sit
• Z-0652-03 · Sep 24, 2002 · Terminated
  Optima URS X-Ray System; Manufactured by SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN