PlainRecalls
FDA Devices Moderate Class II Ongoing

Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471

Reported: March 1, 2023 Initiated: December 21, 2022 #Z-1167-2023

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

Details

Units Affected
2 units; Expanded recall: 53 units
Distribution
US Nationwide distribution.
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie Model Number:10762471. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2 units; Expanded recall: 53 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2023. Severity: Moderate. Recall number: Z-1167-2023.