FDA Device recall Z-1669-2015
SIEMENS Luminos Agile Max
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of SIEMENS Luminos Agile Max by Siemens Medical Solutions Usa, citing study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1669-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-13 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is applicable to emergency treatment on an outpatient basis, as well as for bedside examinations.
Reason
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD subtask card or previous series button on the Image subtask card during image readout. Sporadically, during an automatic or a manual RIS update.
Identifiers
| code_info | Model Number of device 10762472 with serial numbers: 61034 61052 61045 61013 61054 61056 61021 61050 61053…Model Number of device 10762472 with serial numbers: 61034 61052 61045 61013 61054 61056 61021 61050 61053 61032 61015 61046 61028 61040 61011 61029 61048 61060 61042 61035 61014 61025 61043 61036 61038 61022 61037 61049 61044 61062 61030 61018 61027 61061 61033 61039 61047 61031 61041 61055 61019 61057 61059 61017 61051 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1669-2015%22
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