YSIO X.pree 11107464Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04056869232904), received between Aug 8, 2023 and Mar 18, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K201670, K233543); 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 18, 2026.

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.

• MalfunctionMar 18, 2026Device Handling Problem

  SIEMENS HEALTHINEERS WAS NOTIFIED ON MARCH 6, 2026, VIA MEDWATCH REPORT # (B)(4), OF A PATIENT EVENT INVOLVING THE YSIO X. PREE SYSTEM. IT WAS STATED, WHILE MOVING THE PATIENT TABLE, THE PATIENT¿S FINGERS WERE PINCHED. ADDITIONAL FOLLOW-UP BY SIEMENS HEALTHINEERS REVEALED THAT THE PATIENT DID NOT SUSTAIN ANY INJURY FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629194 ↗
• MalfunctionMar 6, 2026

  PATIENT LAYING SUPINE IN AN OBLIQUE POSITION, LEFT SIDE BEING AWAY FROM THE TABLE. TECH WAS STANDING ON THE PT'S RIGHT SIDE. TECH FLOATED TABLE AND PATIENT RESPONDED THAT FINGERS WERE PINCHED. PT'S LEFT HAND HAD BEEN GRASPING AROUND TABLES EDGE. THE TABLE DID NOT GIVE WARNING. UPON INVESTIGATION, TABLE WAS WORKING AS INTENDED. COMPANY CONFIRMED THERE ARE NO SAFETY MECHANISM WHEN UTILIZING FLOATING MOVEMENTS.

  Patient problems: Crushing Injury

  MAUDE report 24531269 ↗
• MalfunctionAug 8, 2023Installation-Related Problem; Installation-Related Problem

  ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023, STATING THAT THE IN-HOUSE ENGINEER CONDUCTED FURTHER TESTS. WHEN THE TUBE IS LOCKED IN PLACE AS DESCRIBED, IT IS NOT SO CLOSE TO THE DOORWAY THAT IT COMPLETELY PREVENTS THE DOOR FROM OPENING, AS INITIALLY REPORTED BY STAFF. IT WAS CONFIRMED THAT EVEN WITH THE TUBE LOCKED IN PLACE, THE MAIN DOOR TO THIS X-RAY ROOM CAN BE OPENED AND A STRETCHER OR WHEELCHAIR CAN BE MOVED THROUGH IF NECESSARY. IT COULD NOT BE CONFIRMED THAT THE DOOR WAS BLOCKED BY THE TUBE. BASED ON THIS INFORMATION, IT WAS CONCLUDED THAT THERE WAS NO HAZARDOUS SITUATION. THE ISSUE IS NO LONGER CONSIDERED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480692 ↗
• MalfunctionAug 8, 2023Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION/CLARIFICATION/CORRECTION: ADDITIONAL INFORMATION REGARDING THE EVENT AND THE PATIENT'S HEALTH STATUS WERE RECEIVED BY SIEMENS HEALTHCARE ON AUGUST 23, 2023. THE FINGER THAT WAS INJURED WAS THE PATIENT'S LEFT MIDDLE FINGER, NOT THE LITTLE FINGER AS INITIALLY REPORTED ON AUGUST 8, 2023. THE PATIENT'S MIDDLE FINGER WAS PINCHED DURING THE COMPLAINT EVENT AND THE SKIN HAD SPLIT AT THE SITE OF THE WOUND AND BLED. THE WOUND WAS DISINFECTED, AND A DRESSING WAS APPLIED. THIS INJURY WAS DETERMINED NOT TO BE A SERIOUS INJURY. TWELVE TO FIFTEEN DAYS FOLLOWING THE INJURY, THE TIP OF THE PATIENT'S LITTLE FINGER WAS AMPUTATED FOR AN UNKNOWN REASON. IT WAS ADDITIONALLY STATED THAT THE PATIENT IS DIABETIC.

  Patient problems: Crushing Injury; Unspecified Tissue Injury

  MAUDE report 17479076 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201670, K233543. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2022 · Mar 7, 2022 · Open, Classified
  YSIO X.Pree
• Z-1346-2021 · Mar 10, 2021 · Terminated
  Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities.