FDA Device recall Z-0999-2026
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
- FDA Device
- Class II
- ongoing
- Published 2026-01-14
On 2026-01-14 the FDA classified a Class II recall of LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471 by Siemens Medical Solutions Usa, citing A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .Wh….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0999-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-05 |
| Published | 2026-01-14 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | n/a |
Product
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Reason
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Identifiers
| code_info | (01)04056869269931(21)10330 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0999-2026%22
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