Affiniti 50 Diagnostic Ultrasound System 795208 (UDI 00884838124981)Recalls & reported problems
Philips Ultrasound LLC · VM12.0 · Class 2
All models of Affiniti 50 Diagnostic Ultrasound System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838124981), received between Dec 11, 2025 and Dec 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THE AFFINITI 50 ULTRASOUND SYSTEM ARRIVED AT THE CUSTOMER SITE WITH A BROKEN MONITOR BRACKET CAUSING A MONITOR DETACHMENT. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE AND NO PATIENT OR USER WAS HARMED. INFORMATION HAS BEEN PROVIDED TO THE CUSTOMER FOR A REPLACEMENT ARTICULATION ARM TO ADDRESS THEIR CONCERNS. 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 23839455 ↗MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED AN AFFINITI 50 ULTRASOUND SYSTEM¿S MONITOR ARM HAD BROKEN AND FALLEN. THIS ISSUE WAS DISCOVERED OUTSIDE OF USE AFTER UNPACKING AND PRIOR TO INSTALLATION. THERE WAS NO REPORTED PATIENT OR USER HARM DUE TO THIS ISSUE. THE FIELD SERVICE ENGINEER REPLACED THE ARTICULATING MONITOR ARM TO RESOLVE THE ISSUE. AN INVESTIGATION IS UNDERWAY TO DETERMINE THE ROOT CAUSE OF THE ISSUE. RESULTS OF THE INVESTIGATION WILL BE INCLUDED IN A FOLLOW UP REPORT UPON ITS COMPLETION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23780397 ↗
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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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