Ultrasound System 5500P 795143Recalls & reported problems
Philips Ultrasound LLC · Compact Series Ultrasound System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838116573), received between May 1, 2025 and May 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Power Up” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 23, 2024Class IIOpen, Classified
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
Z-1757-2024 · Root cause: Component change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2025Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT A COMPACT 5500P CVX ULTRASOUND SYSTEM WAS UNAVAILABLE DURING A CRITICAL PROCEDURE. THE ULTRASOUND SYSTEM WAS UTILIZED TO ASSIST IN MANAGING THE PATIENT¿S RESUSCITATION. THE SYSTEM WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT OR USER ASSOCIATED WITH THIS EVENT. THE PHILIPS FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AND CONDUCTED A HARDWARE AND BATTERY TEST, WHICH PASSED. THE SYSTEM HAS BEEN TAKEN OUT OF SERVICE. PHILIPS HAS STARTED AN INVESTIGATION, AND UPON COMPLETION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945417 ↗
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- Transducer S7-3t 989605439232Philips Ultrasound LLC · System, imaging, pulsed doppler, ultrasonic3 recalls4 reports
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- 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 · each recall links to the FDA recall notice
- 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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