FDA DevicesClass II
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Published: January 14, 2026Recall ID: Z-0999-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Additional Source Details
| Field | Value |
|---|---|
| City | Malvern |
| State | PA |
| Event id | 98230 |
| Address 1 | 40 Liberty Blvd |
| Code info | (01)04056869269931(21)10330 |
| Postal code | 19355-1418 |
| Report date | 20260114 |
| Product type | Devices |
| Product quantity | U.S.: 1, OUS: 95 |
| Reason for recall | 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. |
| Voluntary mandated | FDA Mandated |
| Recall initiation date | 20251205 |
| Center classification date | 20260108 |
Overview
- Recalling FirmSiemens Medical Solutions USA, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. and OUS