Recall Z-0223-2024 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Mobilett Mira wireless (VA20) mobile x-ray system(s)
| Date | Nov 14, 2023 (initiated Oct 5, 2023) |
| Status | Open, Classified |
| Reason | Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor. |
| Root cause | Nonconforming Material/Component |
| Action | Customer notification by means of a Customer Safety Advisory Notice (via electronic mail or FedEx) alerting customers to the lack of acoustic signal issue and providing instructions to monitor the visual indicator (exposure LED light) to avoid additional, unnecessary x-ray dose. The CSAN also includes the plan for the affected D810 boards. The boards (containing the faulty mounting of the buzzer) will be replaced, free of charge, at the customer site with field corrective action XP042/23/P. There is no software update. |
| Quantity | 4 distributed in U.S. |
| Distribution | US Nationwide - Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111912 | MOBILETT MIRA Siemens Medical Solutions USA, Inc., Sep 19, 2011 |