Siemens Medical Solutions USA, Inc Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Serial Numbers 5043 5085 5825 5234 5862 5751 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 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962
Siemens Medical Solutions USA, Inc is recalling Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visuali due to A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Recommended Action
Per FDA guidance
On January 8, 2020, the firm notified customers of the product issue via an Urgent Medical Device Correction letter. Customers were instructed to ensure that the image displayed after acquisition is a newly acquired image and belongs to the current patient. If the error occurs and a previously acquired image is duplicated, the user should delete the image and contact Siemens Customer Service at 1-800-888-7436 to report the incident. Siemens Healthineers will correct the error with a field software update which will be available beginning January 2020. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026