Symbia_Intevo_2 10764802Recalls & reported problems
Siemens Medical Solutions USA, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869001227), received between Jun 27, 2024 and Jun 27, 2024 — classified as 1 injury.
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
Patient problems
- Bone Fracture(s)1
- Crushing Injury1
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON MAY 28, 2024, OF A SIEMENS CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2024. ALLEGEDLY, THE ENGINEER SUSTAINED A FINGER INJURY THAT REQUIRED SURGICAL INTERVENTION WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. THE SERVICE ENGINEER WAS TROUBLESHOOTING THE SYSTEM TRYING TO ISOLATE A NOISE RELATED TO THE PULLEY BELT. THE SERVICE ENGINEER PLACED THEIR FINGER TOO CLOSE TO THE BELT, WHICH ALLOWED CONTACT BETWEEN HIS FINGER AND THE MOVING BELT, AND CAUSING THE INJURY. NO LABELING OR PRODUCT DEFECTS WERE FOUND. THE DESCRIBED EVENT CANNOT CAUSE INJURY TO PATIENTS OR OPERATORS IN A CLINICAL SETTING.
Patient problems: Bone Fracture(s); Crushing Injury; Laceration(s)
MAUDE report 19627539 ↗
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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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