FDA Device recall Z-1338-2020
Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by convert…
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by convert… 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-1338-2020 |
| 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 Agile Max, model no. 10762471 - Product Usage: Luminos Agile 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 61203 61751 61085 61755 61858 61786 61795 61034 61127 61602 61212 61053 61194 61699 61757…Serial Numbers 61203 61751 61085 61755 61858 61786 61795 61034 61127 61602 61212 61053 61194 61699 61757 61752 61200 61738 61799 61875 61603 61624 61885 61848 61243 61606 61682 61087 61888 61052 61889 61226 61854 61079 61218 61110 61137 61123 61763 61621 61622 61623 61788 61798 61837 61892 61193 61700 61743 61652 61229 61045 61838 61239 61632 61190 61013 61659 61102 61724 61063 61054 61784 61213 61651 61056 61088 61146 61681 61678 61873 61720 61716 61027 61021 61145 61824 61050 61210 61211 61240 61227 61185 61779 61140 61181 61061 61158 61242 61074 61209 61075 61686 61094 61032 61769 61608 61711 61869 61169 61223 61083 61234 61660 61661 61849 61143 61670 61616 61723 61754 61684 61249 61691 61130 61668 61806 61717 61174 61740 61722 61777 61126 61255 61855 61015 61183 61046 61804 61625 61731 61748 61845 61822 61863 61719 61829 61162 61125 61156 6171 |
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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-1338-2020%22
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