Avalon CL Base Station Avalon CL BasestationRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Avalon CL Basestation. Basestation for Avalon cableless transducers with three slots for fetal transducers and one slot for maternal parameters or range extenstion module. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884838034228), received between Oct 21, 2024 and May 3, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (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
- False Negative Result1
- Imprecise or Erratic Results1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2026False Negative Result
PHILIPS RECEIVED A COMPLAINT ON AN AVALON CL BASESTATION THAT WHEN THE PATIENT WALKED OUT THE ROOM IT WAS GIVING A FALSE NEGATIVE THAT HER AND THE BABY HEART RATE WAS DROPPING. THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO PATIENT OR USER HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064059 ↗MalfunctionFeb 11, 2026Imprecise or Erratic Results
IT WAS REPORTED THAT THE AVALON CL BASESTATION IS INTERMITTENTLY SWITCHING FROM NORMAL HEARTBEAT. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315998 ↗MalfunctionMar 5, 2025Low Readings; Low Readings
PHILIPS RECEIVED A COMPLAINT ON THE AVALON CL BASE STATION INDICATING THE SYSTEM PRODUCES AN INACCURATE INTRAUTERINE PRESSURE MEASUREMENT. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21525430 ↗MalfunctionOct 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED THAT WHEN USING A WIRELESS POD, THE CONTRACTIONS ARE NOT SHOWING THE WHOLE CONTRACTION IN ORDER TO CORRECTLY ASSESS FETAL HEART RATE. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495949 ↗
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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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