ACUSON P500 Diagnostic Ultrasound System 10785577Recalls & reported problems
Siemens Medical Solutions USA, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04056869002743), received between Feb 3, 2025 and Feb 18, 2026 — classified as 1 death, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Appropriate Device Problem Term/Code Not Available2
- Insufficient Device Problem Information2
- Erratic or Intermittent Display1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available
MEASUREMENTS ARE 3CM INCORRECT (SHORTER THAN EXPECTED), THE MEASUREMENTS ISSUE BEGAN WEDNESDAY (B)(6) 2025 WHILE SCANNING AN ECHO EXAM WITH THE SWIFTLINK CABLE & ACUNAV PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376623 ↗DeathFeb 18, 2026Appropriate Device Problem Term/Code Not Available
WAS NOT PROVIDED IN DETAIL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24376621 ↗MalfunctionFeb 3, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: THE IMAGE JERKS. INSPECTED WITH OTHER EQUIPMENT. EXAM: ABLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21293159 ↗MalfunctionFeb 3, 2025Power Problem; Power Problem
THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: * CUSTOMER REPORTS SYSTEM TURNED OFF DURING THE MIDDLE OF AN EXAM. * AFIB ABLATION WITH ICE CATHETER. * NO INJURIES, CUSTOMER ABLE TO COMPLETE EXAM WITH ANOTHER ULTRASOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21291904 ↗MalfunctionFeb 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: CATHETER IMAGES ARE NOT DISPLAYED. EXAM; ABLATION. THE P500 FAILED, SO WE USED A DIFFERENT SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21290779 ↗MalfunctionFeb 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: THE CARD IS NOT DISPLAYED ON THE CARTO SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21290588 ↗
Other System, imaging, pulsed doppler, ultrasonic devices
- Transducer C5-1 989605412042Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic11 recalls0 reports
- Transducer X5-1 989605400802Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic10 recalls0 reports
- EPIQ 7 Diagnostic Ultrasound System 989605386721Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls2 deaths146 reports
- Transducer S7-3t 989605406772Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic5 recalls1 death18 reports
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180Olympus Medical Systems Corp. · System, imaging, pulsed doppler, ultrasonic199 reports
- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
- Transducer 3D9-3v 989605395622Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls1 report
- ACUSON Redwood Diagnostic Ultrasound System 11503314Siemens Medical Solutions USA, Inc. · System, imaging, pulsed doppler, ultrasonic3 recalls0 reports
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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