System, X-ray, Film Marking, Radiographic
Beekley Corporation's record for this product code
Recent MDR events
21 adverse event reports on file
- A-SPOTJun 23, 2026Injury9021987-2026-00003
- TOMOSPOTApr 2, 2026Injury9021987-2026-00001
- CT-SPOTSep 2, 2025Injury9021987-2025-00001
- TOMOSPOT AND V-SPOTDec 18, 2024Injury9021987-2024-00004
- O-SPOTMay 20, 2024Injury9021987-2024-00002
- TOMOSPOTNov 15, 2019Injury9021987-2019-00004
- CT-SPOTSep 9, 2019Injury9021987-2019-00003
- CT-SPOTJul 19, 2019Injury9021987-2019-00002
- TOMOSPOTMay 6, 2019Injury9021987-2019-00001
- A-SPOTOct 22, 2018Injury9021987-2018-00005
Recalls
8 recall events for this product code
- TerminatedJul 31, 2012
Digital Skin Mammography Marker separating from the backing of the spot material
View FDA record ↗ - TerminatedJul 31, 2012
Digital Skin Mammography Marker separating from the backing of the spot material
View FDA record ↗ - TerminatedJul 31, 2012
Digital Skin Mammography Marker separating from the backing of the spot material
View FDA record ↗ - TerminatedJul 31, 2012
Digital Skin Mammography Marker separating from the backing of the spot material
View FDA record ↗ - TerminatedUnknown
Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
View FDA record ↗ - TerminatedUnknown
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
View FDA record ↗ - TerminatedUnknown
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
View FDA record ↗ - TerminatedUnknown
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Beekley Corporation under this product code.