Biograph Vision 450 Edge 10749671Recalls & 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 04056869238081), received between Mar 27, 2024 and Mar 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
- 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.
InjuryMar 27, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SIEMENS MEDICAL SOLUTIONS USA, INC. WAS NOTIFIED ON MARCH 8, 2024, OF A CUSTOMER SERVICE ENGINEER INJURY THAT OCCURRED ON (B)(6) 2024. A PERMANENT FINGER INJURY WAS SUSTAINED WHILE SERVICING THE DEVICE CONTRARY TO THE SERVICE INSTRUCTIONS. THERE ARE NO PRODUCT DEFECTS OR FAILURES. THERE ARE NO LABELING DEFECTS. THERE WERE NO OTHER INJURIES TO ANY OTHER PERSONS.
Patient problems: Crushing Injury; Laceration(s)
MAUDE report 18989528 ↗
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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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