Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic...
FDA Recall #Z-1164-2023 — Class II — December 21, 2022
Product Description
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model Number: 10502200
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
4 units. Expanded Recall: 93 units
Distribution
US Nationwide distribution.
Code Information
UDI: N/A S/N: 60040 60018 60223 60015 Expanded Recall 2/24/23: S/N: 60011 60037 60041 60043 60051 60055 60056 60062 60067 60071 60072 60075 60076 60081 60087 60089 60092 60093 60095 60103 60111 60114 60118 60133 60138 60140 60141 60143 60146 60155 60162 60171 60172 60173 60178 60183 60184 60186 60187 60188 60192 60194 60196 60204 60208 60214 60219 60220 60221 60225 60227 60228 60230 60231 60234 60238 60239 60255 60259 60262 60264 60267 60273 60274 60277 60279 60286 60404 60408 60409 60412 60413 60414 60416 60417 60423 60424 60425 60429 60433 60436 60440 60441 60445 60446 60450 60452 60459 60464 60465 60466 60469 60473
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated