Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200
- Recall Initiated
- December 21, 2022
- Posted
- February 23, 2023
- Recall Number
- Z-1166-2023
- Quantity
- 1 unit; Expanded Recall: 25 units
- Firm Location
- Malvern, PA
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
US Nationwide distribution.
Lot / Code Info
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
Root Cause
Software design
Action Taken
***UPDATE*** Siemens issued Urgent Medical Device Correction letter (expansion) via CSAN XP056/22/S to affected customers on 2/24/2023. The CSAN alerts the users to the issue warning them to pay special attention to the travel range of system parts. The CSAN urges users to stop system movement to prevent collision by releasing the movement control or by activating the emergency stop button as described in the system Operator Manual. Field corrective action via XP057/22/S will initiate an onsite visit to the customer facilities by a Siemens Customer Service Engineer to check the room configuration parameters current set on the systems and, if necessary, restore them to the correct values. This service will be provided to the customers free of charge. Customers with software version VF11 will be addressed under a separate and to be determined UI (update to VF11H). If you have any technical questions or desire an earlier appointment, please contact our service organization at 1-800-888-7436. _______________________________ ___________________________________________ Siemens Medical Solutions issued Customer Safety Advisory Notification( CSAN XP053/22/S) beginning on December 21, 2022. Letter states reason for recall, health risk and action to take: When performing unit movements, the user should pay special attention to the travel range of the system parts and stop movement in time to prevent a collision with the ceiling, wall, or objects. System movement can be stopped by releasing the movement control or by activating the emergency stop button as described in the system Operator Manual. Customer Safety Advisory Notice (XP053/22/S) will be distributed to all affected customers. Field corrective action via XP054/22/S will initiate an onsite visit of a Siemens Customer Service Engineer to check the room configuration parameters currently set for your system and if necessary, restore them to the correct values. These visits will be free of charge. The Siemens Service Or