Expression MR Wireless ECG Patient Module (Gen 3) 1-5 Wireless ECG 3.0 Module (Networks 1-5)Recalls & reported problems
Philips Ds North America LLC · 3rd-Generation wireless ECG module for Expression MRI patient monitors (Networks 1-5). · 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 00884838055001), received between Jul 18, 2024 and Jul 18, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (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
- Application Program Freezes or Fails to Launch1
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.
MalfunctionJul 18, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THAT THE SYSTEM MODULE HANGS DURING BOOT UP. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19776260 ↗
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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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