medical Class II Updated 2020-08-12

Siemens Medical Solutions USA, Inc recalls SIEMENS Healthineers Luminos dRF Max Model: 10762471- Prod

Recalled Product

SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.

Hazard / Issue

Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 5043 5085 5825 5234 5862 5751 5340 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962
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