YSIO X.pree 11574001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869962214), received between Mar 13, 2026 and Mar 19, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Image Orientation Incorrect” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Insufficient Device Problem Information

  SIEMENS HEALTHINESS WAS NOTIFIED OF AN ISSUE WITH THE YSIO X. PREE GEN2 SYSTEM DURING A PATIENT EXAMINATION. IT WAS COMMUNICATED THAT DURING A LATERAL CHEST X-RAY PROCEDURE, THE STRETCH GRIP DETACHED AND FELL. THE USER HAD THEIR HEAD BELOW THE GRIP AND WAS STRUCK ON THE HEAD BY THE DETACHED GRIP. THE USER WAS DIAGNOSED WITH A CONCUSSION AS A RESULT OF THE IMPACT. NO INJURY OF THE PATIENT WAS COMMUNICATED.

  Patient problems: Concussion

  MAUDE report 24639286 ↗
• InjuryMar 13, 2026Image Orientation Incorrect

  SIEMENS HEALTHINEERS WAS NOTIFIED OF A PATIENT INJURY INVOLVING THE YSIO X. PREE GEN2 SYSTEM. IT WAS STATED THAT A FLIPPED IMAGE WAS USED FOR SURGICAL PLANNING RESULTING IN THE SURGERY BEING PERFORMED ON THE WRONG HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24589012 ↗