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Xact
Solstice Corporation · Model M15R · UDI-DI 00854623006136
10
510(k) clearances
24
Adverse events
15
Recalls
37
Facilities
Description
X-ray imaging marker for extremities, 15mm circle, 60/box https://xactmarkers.com/product/skeletal-ring-markers-m15r/
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-13 | Beekley Corporation | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| 2018-06-13 | Beekley Corporation | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| 2018-06-13 | Beekley Corporation | There is a potential for imaging artifact to mimic calcifications on patient's mammograms |
| 2017-05-08 | Beekley Corporation | Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels |
| 2012-09-26 | GE Healthcare, LLC | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display differe |
| 2012-09-26 | GE Healthcare, LLC | When quickly switching the protocols from AEC to Fixed under the same view, if the user selection process time is less than 0.5 seconds, the User Interface (UI) may display differe |
| 2012-08-03 | GE Healthcare, LLC | GE Healthcare has become aware of a software issue on the interface of the Brivo XR385 DR-F/ Model 5271997 radiographic product related to Visual indication as mandated by the US C |
| 2012-07-09 | Beekley Corporation | Digital Skin Mammography Marker separating from the backing of the spot material |
| 2012-07-09 | Beekley Corporation | Digital Skin Mammography Marker separating from the backing of the spot material |
| 2012-07-09 | Beekley Corporation | Digital Skin Mammography Marker separating from the backing of the spot material |
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