Device product
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
Z-1166-2023
Product summary
- Event
- Event 91649
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit; Expanded Recall: 25 units
- Official record key
device-enforcement:Z-1166-2023
Official wording
Reason: 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
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
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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