Philips dS Breast Coil 7ch 1.5TRecalls & reported problems
Philips Ds North America LLC · dS Breast Coil 7ch 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 00884838085541), received between May 10, 2024 and May 10, 2024 — 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
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2024Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO THE INSUFFICIENT MEDIAL COMPRESSION PLATE IN THE MRI, A LARGE DEFECT IN THE BREAST OCCURRED DURING A VACUUM BIOPSY. THERE IS NO INDICATION OF A COIL OR SYSTEM MALFUNCTION.
Patient problems: Laceration(s)
MAUDE report 19292436 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page