Recall Z-1167-2023 ยท OWB Interventional Fluoroscopic X-Ray System
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
| Date | Feb 23, 2023 (initiated Dec 21, 2022) |
| Status | Open, Classified |
| 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 configurat |
| Quantity | 2 units; Expanded recall: 53 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax Siemens Medi Cal Solutions, Inc., Apr 2, 2018 |