FDA Device recall Z-0005-2015
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic s…
- FDA Device
- Class II
- terminated
- Published 2014-10-08
On 2014-10-08 the FDA classified a Class II recall of Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic s… by Siemens Medical Solutions Usa, citing two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0005-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-02 |
| Published | 2014-10-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as 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
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images
Identifiers
| code_info | Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015 61011 61014 61017 |
|---|
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-0005-2015%22
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