Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic st...
FDA Recall #Z-1166-2023 — Class II — December 21, 2022
Product Description
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
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
1 unit; Expanded Recall: 25 units
Distribution
US Nationwide distribution.
Code Information
UDI: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 4734
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated