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

Recall number

Z-1167-2023

Recalling firm

Siemens Medical Solutions USA, Inc

Product

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

Status

Open, Classified

Initiated

2022-12-21

Posted

2023-02-23

Terminated

not on file

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

Root cause

Software design

Action

***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

Quantity

2 units; Expanded recall: 53 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

UDI: 4056869009162 S/N: 5037 5951 Expanded Recall 2/24/23: 5069 5085 5209 5234 5340 5364 5634 5664 5682 5919 5920 5921 5947 5953 5954 5956 5963 7075 7098 7147 7162 7168 7172 7208 7266 7310 7319 7391 7404 7442 7460 7488 7545 7743 7771 8074 8093 8094 8183 8198 8223 8242 8244 8275 8320 8322 8334 8361 8371 8378 8385 8389

510(k) numbers

["K173639"]

PMA numbers

not on file

Product code

OWB

Firm FEI

2240869

Firm city

Malvern

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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