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CT-Markers
Nucletron B.V. · Model 189086P01-00 · UDI-DI 08717213040281
JAC
Prescription
10
510(k) clearances
25
Adverse events
15
Recalls
37
Facilities
Description
CT Marker 240 mm, Black
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.