SEDECAL Soltus 500 (REF 10501)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08436046002456), received between Jul 22, 2022 and Dec 15, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Unintended System Motion” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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

1. Aug 12, 2022Open, Classified

   Due to un-commanded movement of mobile x-ray unit.

   Z-0182-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Unintended System Motion; Unintended System Motion

  TECHNICIAN MM , RADIOLOGY TECHNOLOGIST, NIGHT SHIFT WAS COMING DOWN RAMP FROM HPMC ED TO RADIOLOGY DEPARTMENT WITH CANON SOLTUS 450ST MOBILE X-RAY UNIT "K", SN# (B)(4) AND IT SUDDENLY WENT INTO REVERSE WITHOUT WARNING. MARLON WAS PINNED AGAINST RAILING WALL AND INJURED HAND.. THE X-RAY UNIT WAS DAMAGED - THE PLASTIC FRAME UNDER HANDLE IN FRONT BROKE OFF., RADIOLOGY TECHNOLOGIST, NIGHT SHIFT WAS COMING DOWN RAMP FROM HPMC ED TO RADIOLOGY DEPARTMENT WITH CANON SOLTUS 450ST MOBILE X-RAY UNIT "K", SN# (B)(4) AND IT SUDDENLY WENT INTO REVERSE WITHOUT WARNING. MM WAS PINNED AGAINST RAILING WALL AND INJURED HAND.. THE X-RAY UNIT WAS DAMAGED - THE PLASTIC FRAME UNDER HANDLE IN FRONT BROKE OFF.

  Patient problems: Bruise/Contusion

  MAUDE report 15986297 ↗
• MalfunctionJul 22, 2022Unintended System Motion; Unintended System Motion

  AFTER USING THE MOBILE, THE MOBILE LIGHT WENT RED AS THE X-RAY TECHNOLOGIST WAS BACKING OUT OF A PATIENT'S ROOM. THE X-RAY TECHNOLOGIST RE-DOCKED THE TUBE IN AN ATTEMPT TO RESET THE MOBILE MACHINE, AND HEADED BACK TO THE DEPARTMENT WITH THE MOBILE DRIVING IN "TURTLE" MODE AND THE TUBE HEAD LIGHT SHOWING RED. WHILE RETURNING BACK TO THE DEPARTMENT, MID TURN THE MOBILE WENT FULL SPEED UNCONTROLLABLY IN REVERSE AND SLAMMED INTO THE WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085434 ↗
• MalfunctionJul 22, 2022Unintended System Motion; Unintended System Motion

  ON (B)(6)2022 AT APPROXIMATELY 10:50 AM THE TECH WAS FINISHING TAKING X-RAYS IN A PATIENT ROOM ON THE 4TH FLOOR. WHILE SHE WAS ATTEMPTING TO BACK THE PORTABLE OUT OF THE ROOM SHE BEGAN HAVING DIFFICULTY WITH THE PORTABLE JERKING. SHE NOTICED A FLASHING RED LIGHT AT THE TIME. ONCE SHE GOT THE PORTABLE OUT OF THE ROOM THE TUBE HEAD LIGHT WAS STILL FLASHING RED. SHE CYCLED POWER TO THE PORTABLE AND SHE WAS STILL GETTING THE FLASHING RED LIGHT. WHEN ATTEMPTING TO TAKE THE PORTABLE BACK TO THE IMAGING DEPARTMENT THE SOLTUS MOTORS WERE NOT ENGAGING AND MOVING FORWARD. THE TECH HAD TO USE HER STRENGTH TO PUSH THE PORTABLE DOWN A HALL 20 FEET BEFORE MAKING A RIGHT TURN AND CONTINUING ABOUT ANOTHER 15 FEET BEFORE THE PORTABLE STARTED BACKING UP ON ITS OWN. THE TECH SAID THE SPEED AT WHICH THE PORTABLE WAS GOING BACKWARDS INCREASED AT WHICH TIME SHE LET GO OF THE HANDLE AND THE PORTABLE BEGAN SPINNING WHILE GOING IN REVERSE. ITS MOTION WAS ONLY STOPPED WHEN HITTING A CONCRETE PILLAR IN THE HOSPITAL HALLWAY. THE BIOMED WAS THEN CALLED. WHEN HE ARRIVED HE ACTIVATED THE E-STOP AND REMOVED THE WHEEL BOLTS THAT CONNECT THE WHEELS TO THE MOTORS. HE THEN PUSHED THE PORTABLE OUT OF THE HALLWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085416 ↗
• MalfunctionJul 22, 2022Unintended System Motion; Unintended System Motion

  THE UNIT FAILED TO MOVE FORWARD WITH A RED LED ON THE TUBE HEAD INDICATING AN ERROR, THE OPERATOR THEN SHUTDOWN AND REBOOTED THE SYSTEM BUT STILL ENCOUNTERED THE SAME ISSUE. TWO TECHS ATTEMPTED TO MOVE THE PORTABLE TO GET IT OUT OF THE HALLWAY. THE PORTABLE ALL OF A SUDDEN ENGAGED BUT STARTED MOVING BACKWARD AT A HIGH RATE OF SPEED. THE TECHS LET GO OF THE PORTABLE AND IT KEPT MOVING AND RAN OVER THE TECHNOLOGIST'S FOOT. THE FACILITY INDICATED THAT THERE WAS NO SERIOUS INJURY AND MADE THE DETERMINATION THAT A VOLUNTARY 3500 FORM WAS NOT REQUIRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15085406 ↗