FDA Device recall Z-1337-2020
Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting… by Siemens Medical Solutions Usa, citing A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1337-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-08 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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.
Reason
A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.
Identifiers
| code_info | Serial Numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1337-2020%22
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