Multix Fusion VA10 10746665Recalls & reported problems
Siemens Shanghai Medical Equipment Ltd. · Radiography System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869019888), received between Mar 26, 2021 and Sep 17, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Mechanical Problem1
Patient problems
- Multiple Fractures1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
SIEMENS HEALTHINEERS BECAME AWARE OF SERIOUS PATIENT INJURY ASSOCIATED WITH THE MULTIX FUSION SYSTEM. THE CUSTOMER COMMUNICATED TO SIEMENS HEALTHINEERS ON (B)(6) 2025 THAT THE FOLLOWING INCIDENT HAD OCCURRED ON (B)(6) 2025: DURING A WRIST EXAMINATION, THE PATIENT WAS SITTING SIDEWAYS TO THE TABLE. THE USER INFORMED THAT PATIENT THAT THEY WOULD LOWER THE TABLE. IN THAT MOMENT THE PATIENT PULLED THEIR LEGS BENEATH THE TABLE BASE. THIS RESULTED IN A COLLISION OF THE TABLE WITH THE PATIENT¿S LEGS. CONSEQUENTLY, THE PATIENT SUFFERED A TIBIA AND FIBULA FRACTURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING TREATMENT OF THE PATIENT¿S FRACTURES AND CURRENT HEALTH STATUS. THIS INFORMATION IS PENDING RECEIPT BY SIEMENS HEALTHINEERS. THERE IS A WARNING LABEL REGARDING LEG CRUSHING ON THE SYSTEM IN THE VICINITY OF THE COLLISION AREA TO ALERT THE OPERATOR AND PATIENT OF THIS HAZARD. IN ADDITION, THERE IS A NOTE IN THE OPERATOR MANUAL TO NOT START MOTORIZED VERTICAL TABLE MOVEMENT WHEN BODY PARTS ARE POSITIONED BENEATH THE TABLE IN THE OPERATOR MANUAL.
Patient problems: Multiple Fractures
MAUDE report 23071625 ↗MalfunctionMar 26, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component
DURING A SERVICE CALL, SIEMENS BECAME AWARE OF AN EVENT OCCURRED ON THE MULTIX FUSION UNIT. THE INCIDENT OCCURRED WITH THE TRANSVERSE CARRIAGE. WHEN THE USER MOVED THE 3D STAND TRANSVERSELY TO ALIGN THE TUBE TO A WALL STAND, THE FRONT COVER ON THE TRANSVERSE CARRIAGE FELL DOWN TO THE FLOOR WITH TWO END STOPPERS AND THE TWO OF THE 3D STAND WHEELS RAN OFF THE RAILS TRACK. THIS RESULTED IN THE 3D STAND BEING STUCK WITH NO FURTHER MOVEMENT POSSIBLE. THERE ARE NO INJURIES ATTRIBUTED TO THE EVENT. THE REPORTED INCIDENT OCCURRED IN (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11575289 ↗
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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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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