TomoSPOT 783Recalls & reported problems
Beekley Corporation · Scar Markers, low density see-through line, pinch-free material · Class 1
Data updated Oct 16, 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 00815137020506), received between May 6, 2019 and May 6, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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
- Device Slipped1
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.
InjuryMay 6, 2019Device Slipped
A SCAR MARKER FELL OFF A PATIENT DURING A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8582000 ↗
Other System, X-Ray, Film Marking, Radiographic devices
- CT-SPOT 118Beekley Corporation · System, X-Ray, Film Marking, Radiographic3 reports
- A-SPOT 651Beekley Corporation · System, X-Ray, Film Marking, Radiographic2 reports
- TomoSPOT 784Beekley Corporation · System, X-Ray, Film Marking, Radiographic2 reports
- TomoSPOT 782Beekley Corporation · System, X-Ray, Film Marking, Radiographic2 reports
- O-SPOT 609Beekley Corporation · System, X-Ray, Film Marking, Radiographic1 report
- O-SPOT 791Beekley Corporation · System, X-Ray, Film Marking, Radiographic1 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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