Z-2755-2020 Class II Terminated
FDA device recall Z-2755-2020 was initiated by Siemens Medical Solutions USA, Inc on January 8, 2020 and is designated Class II. Reason for recall: 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 und… The recall status is terminated (terminated June 21, 2022). Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 12, 2020
- Initiation Date
- January 8, 2020
- Termination Date
- June 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
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.
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
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