Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and...
FDA Recall #Z-1167-2023 — Class II — December 21, 2022
Product Description
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471
Reason for Recall
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 units; Expanded recall: 53 units
Distribution
US Nationwide distribution.
Code Information
UDI: 4056869009162 S/N: 5037 5951 Expanded Recall 2/24/23: 5069 5085 5209 5234 5340 5364 5634 5664 5682 5919 5920 5921 5947 5953 5954 5956 5963 7075 7098 7147 7162 7168 7172 7208 7266 7310 7319 7391 7404 7442 7460 7488 7545 7743 7771 8074 8093 8094 8183 8198 8223 8242 8244 8275 8320 8322 8334 8361 8371 8378 8385 8389
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated