AFFINITI CVX DIAGNOSTIC ULTRASOUND SYSTEM 795190 (UDI 00884838101043)Recalls & reported problems
Philips Ultrasound LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838101043), received between Nov 17, 2021 and Nov 17, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended System Motion” (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.
Most reported problems
Device problems
- Unintended System Motion1
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.
MalfunctionNov 17, 2021Unintended System Motion; Unintended System Motion
THE CUSTOMER REPORTED AN INCIDENT WHERE THE SWIVEL MECHANISM OF THEIR AFFINITI CVX ULTRASOUND SYSTEM¿S CONTROL PANEL WOULD NOT LOCK INTO POSITION WHILE TRANSPORTING THE UNIT WITHIN THE USER FACILITY. A PHILIPS SERVICE ENGINEER TIGHTENED AN INTERNAL SCREW TO REPAIR THE SYSTEM. NO PATIENT OR USER WAS HARMED AS A RESULT OF THE ISSUE. THE ULTRASOUND SYSTEM HAS BEEN RETURNED TO SERVICE WITH NO ADDITIONAL ISSUES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12831915 ↗
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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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