Avalon CL Fetal & Maternal PodRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · The Avalon CL Fetal & Maternal Pod enables the Avalon wearable solution. It is used together with the Avalon CL Basestation 866074. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838068179), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Temperature Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Temperature Problem1
Patient problems
- Local Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Temperature Problem; Adverse Event Without Identified Device or Use Problem; Temperature Problem
IT WAS REPORTED THE PATIENT DEVELOPED A SKIN REACTION UNDER THE PATCHES OF THE BELTLESS SOLUTION. PER THE PROVIDED PICTURE, A CRUST OR SCAB FORMED IN A CIRCULAR PATTERN WHERE THE PATCHES WERE APPLIED. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.
Patient problems: Local Reaction
MAUDE report 23826566 ↗
Other Monitor, uterine contraction, external (for use in clinic) devices
- Avalon CL Toco+ MP Transducer Avalon Cableless Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbH · MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)13 reports
- Avalon TOCO MP TransducerPhilips Medizin Systeme Böblingen GmbH · MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)8 reports
- Avalon TOCO+ TransducerPhilips Medizin Systeme Böblingen GmbH · MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)5 reports
- Avalon Fetal & Maternal Patch Avalon CL Fetal & Maternal PatchPhilips Medical Systems Hsg · Monitor, uterine contraction, external (for use in clinic)3 reports
- Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbH · Monitor, uterine contraction, external (for use in clinic)1 report
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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