Device product
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Z-1668-2015
Product summary
- Event
- Event 71115
- Status
- Terminated
- Classification
- Class II
- Quantity
- 133 total
- Official record key
device-enforcement:Z-1668-2015
Official wording
Reason: Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
Code information: Model Number of device 10762471with serial numbers: 5043 5085 5069 5086 5037 5072 5049 5039 5120
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.