Recall Z-0523-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
| Date | Dec 9, 2023 (initiated Oct 17, 2023) |
| Status | Open, Classified |
| Reason | Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage. |
| Root cause | Component design/selection |
| Action | On October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mit |
| Quantity | 38 worldwide, 11 US |
| Distribution | US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221516 | ARTIS icono (Ceiling Configuration) Siemens Medical Solutions USA, Inc., Jul 19, 2022 |