Affirm Prone Biopsy System PBX-SYS-AFFIRM-2DRecalls & reported problems
Hologic, Inc. · AFFIRM PRONE BIOPSY SYSTEM, 2D · Class 2
All models of Affirm Prone Biopsy System (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 15420045506503), received between Feb 25, 2020 and Feb 25, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended System Motion” (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
- Unintended System Motion1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2020Unintended System Motion; Unintended System Motion
IT WAS REPORTED THAT THE TABLE AUTO MOVE UP WITHOUT PRESSING ANY BUTTON. NO INJURY REPORTED. A FIELD ENGINEER WAS DISPATCHED TO THE SITE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9751424 ↗
Other System, x-ray, mammographic devices
- Affirm Lateral Arm Upright Biopsy Accessory ASY-03723Hologic, Inc. · System, x-ray, mammographic1 recall3 reports
- Affirm Breast Biopsy Guidance System STLC-00004Hologic, Inc. · System, x-ray, mammographic24 reports
- Affirm Prone Biopsy System PBX-SYS-AFFIRM-3DHologic, Inc. · System, x-ray, mammographic23 reports
- Multicare Platinum 8-004-0017Hologic, Inc. · System, x-ray, mammographic2 reports
- FDR-2000BPY POSITIONER KIT BPY-L HA USA EFujifilm Corporation · System, X-Ray, Mammographic2 reports
- 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 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