Recall Z-0979-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis Q.zen ceiling, Model Number 10848354
| Date | Apr 21, 2022 (initiated Feb 23, 2022) |
| Status | Open, Classified |
| Reason | If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT". |
| Root cause | Device Design |
| Action | An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 2/23/22 was sent to customers. Which steps have to be taken by the user to avoid the possible risks associated with this problem? As also described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water, if necessary: 1. Open the filling gland of the cooling unit. The water surface must be clearly visible above the cooling ribs. 2. Replenish with water (drinking water quality) if cooling liquid is lacking. Please inform the service t |
| Quantity | 81 systems |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181407 | Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc., Aug 15, 2018 |