Invivo 45980009799Recalls & reported problems
Philips Ds North America LLC · dS HeadNeck 3.0T · Class 2
All models of Invivo (19)
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 00884838067394), received between Dec 10, 2018 and Dec 10, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Device Fell1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2018Device Dislodged or Dislocated; Device Fell
WHILE BEING SCANNED, MIRROR ASSEMBLY WAS ATTACHED TO THE MRI COIL. A SCREW HAD PREVIOUSLY FELL OUT OF THE ASSEMBLY AND DURING THE SCAN THE MIRROR DISLODGED FROM THE ASSEMBLY AND FELL TO HIT THE PATIENT'S EYE. NO MEDICAL INTERVENTION WAS NECESSARY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147940 ↗
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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