Z-1166-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2023
- Initiation Date
- December 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit; Expanded Recall: 25 units
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
Distribution Pattern
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