Multicare Platinum 8-004-0017Recalls & reported problems
Hologic, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045505926), received between Nov 27, 2018 and Jan 24, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Electrical Shorting1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2023Electrical Shorting; Electrical Shorting
IT WAS REPORTED THAT FOR A MULTICARE PLATINUM , THE EQUIPMENT WOULD NOT START AND WOULD SMELL LIKE BURNED. ON DECEMBER 29TH A FIELD ENGINEER EXAMINED THE CONSOLE AND DETERMINED THAT THE ISSUE OCCURRED DURING THE STARTUP OF THE SYSTEM AND THAT THERE WERE NO PATIENTS DURING THE PROBLEM. THE CUSTOMER REPORTED AT THAT POINT THAT WHEN THEY STARTED THE COMPUTER THEY OBSERVED A SMALL FIRE COMING FROM THE DSM AND IMMEDIATELY ACTIVATED THE SAFETY DEVICE WHICH UNPLUGGED EVERYTHING. THE ENGINEER ON SITE CONFIRMED THAT THE PROBLEM CAME FROM THE TRANSFORMER. NO INJURY WAS REPORTED TO STAFF OR PATIENT. THE PARTS DAMAGED WILL BE REPLACED. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16236807 ↗MalfunctionNov 27, 2018Break; Incorrect, Inadequate or Imprecise Result or Readings
WILE PERFORMING DAILY QC ON THE STEREOTACTIC UNIT, THE TECH DISCOVERED THAT THE NEEDLE TEST WAS OUT OF LIMITS AND THE COMPRESSION PADDLE LOCK WAS BROKEN. DUE TO THIS EVENT THE PATIENT/EXAM DOUBLE STEREO SCHEDULED FOR TODAY WAS NOT ABLE TO BE DONE AND A SINGLE SCORE BIOPSY HAD TO BE COMPLETED IN THE ULTRASOUND DEPT. PATIENT WILL POSSIBLY HAVE TO RETURN ON ANOTHER DAY TO HAVE THE STEREOTACTIC BIOPSY DONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8105467 ↗
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- Bella Blankets 311Beekley Corporation · System, X-Ray, Mammographic1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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