Symbia_Evo 10910500Recalls & reported problems
Siemens Medical Solutions USA, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869001258), received between May 10, 2024 and May 16, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Laceration(s)2
- Bone Fracture(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON APRIL 17, 2024, OF A CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON FEBRUARY 1, 2022. ALLEGEDLY, THE ENGINEER SUSTAINED A FRACTURE AND LACERATION INJURY TO HIS HAND THAT REQUIRED STITCHES, WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. NO LABELING OR PRODUCT DEFECTS WERE FOUND. THE DESCRIBED EVENT CANNOT CAUSE INJURY TO PATIENTS OR OPERATORS WHILE IN CLINICAL USE AT A USER FACILITY.
Patient problems: Bone Fracture(s); Laceration(s)
MAUDE report 19333296 ↗InjuryMay 10, 2024Use of Device Problem; Use of Device Problem
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON APRIL 10, 2024, OF A CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2024. ALLEGEDLY, THE ENGINEER SUSTAINED AN INJURY TO HIS HAND THAT REQUIRED STITCHES, WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. NO LABELING OR PRODUCT DEFECTS WERE FOUND. THE DESCRIBED EVENT CANNOT CAUSE INJURY TO PATIENTS OR OPERATORS WHILE IN CLINICAL USE AT A USER FACILITY.
Patient problems: Laceration(s)
MAUDE report 19287999 ↗
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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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