SIEMENS Healthineers Luminos dRF Max recall: Software Issue
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray…
Why was SIEMENS Healthineers Luminos dRF Max recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 49 units
- Distribution
- US Nationwide distribution.
- Recall date
- August 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)