Philips Sentinelle SMS 16ch Breast 1.5TRecalls & reported problems
Philips Ds North America LLC · Breast MRI 16ch Tabletop for Siemens 1.5T · 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 00884838081598), received between Apr 30, 2026 and Apr 30, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
Patient problems
- Burn(s)1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2026Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
PHILIPS RECEIVED A REPORT ABOUT A POTENTIAL HEATING INCIDENT DURING A BREAST EXAMINATION WHILST USING THE 16 CHANNEL BREAST COIL. IT WAS REPORTED THE PATIENT COMPLAINED OF A BURN ON THE UNDERSIDE OF BOTH BREASTS. NO OTHER CLINICAL OR MEDICAL INFORMATION WAS PROVIDED.
Patient problems: Burn(s); Insufficient Information
MAUDE report 25040527 ↗
Other Coil, Magnetic Resonance, Specialty devices
- NA SIGNA PremierGE Medical Systems, L.L.C. · Coil, magnetic resonance, specialty3 recalls0 reports
- NA SIGNA PremierGE Medical Systems, L.L.C. · Coil, magnetic resonance, specialty3 recalls0 reports
- MAGNETOM Skyra 10849580Siemens Healthcare GmbH · Coil, magnetic resonance, specialty2 recalls2 reports
- MAGNETOM Altea 11410371Siemens Healthcare GmbH · Coil, magnetic resonance, specialty1 recall2 reports
- MAGNETOM Spectra 10837643Siemens Shenzhen Magnetic Resonance Ltd. · Coil, magnetic resonance, specialty1 recall1 report
- MR Coils dS Breast 16ch 3.0TPhilips Medical Systems Nederland B.V. · Coil, Magnetic Resonance, Specialty1 recall0 reports
- Invivo 45353028072Philips Ds North America LLC · Coil, magnetic resonance, specialty1 recall0 reports
- Philips dS Breast 7ch 3.0TPhilips Ds North America LLC · Coil, magnetic resonance, specialty1 recall0 reports
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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