Z-0999-2026 Class II Ongoing
FDA device recall Z-0999-2026 was initiated by Siemens Medical Solutions USA, Inc on December 5, 2025 and is designated Class II. 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 quickl… The recall status is ongoing. Affected quantity: U.S.: 1, OUS: 95.
Recall Details
- Product Type
- Devices
- Report Date
- January 14, 2026
- Initiation Date
- December 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- U.S.: 1, OUS: 95
Product Description
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
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.
Distribution Pattern
U.S. and OUS
Code Information
(01)04056869269931(21)10330