InjuryJAC
TOMOSPOT
Received Nov 15, 2019 · Event occurred Oct 29, 2019
Report 9021987-2019-00004 · MDR key 9330391
Device
Generic name
Palpable Mass Marker
Manufacturer
Beekley CorporationModel number
784Catalog number
784
Lot number
784.05231801
Product problems
- Image Display Error/Artifact
- Nonstandard Device
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
TOMOSPOT LOT 784.05231801 WAS PART OF RECALL 9021987-6/14/18-001-R.
Description of Event or Problem
A PALPABLE MASS MARKER CAUSED ARTIFACT ON A MAMMOGRAM. AS A RESULT, THE MAMMOGRAM WAS REPEATED.