Siemens Medical Solutions USA, Inc Recall 89860
Description: Artis Q.zen floor, Model Number 10848353
Siemens Medical Solutions USA, Inc Recall 89860 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0978-2022 |
| Event ID | 89860 |
| Event Description | Artis Q.zen floor, Model Number 10848353 |
| Product Type | Devices |
| Distribution | US Nationwide. |
| Quantity | 33 systems |
| Recall 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". |
| Device Classification | 20220427 |
| Device Code Info | UDI: 4056869010014; Serial Numbers: 105120 105110 105033 105032 105500 105105 105028 105503 105018 105114 105115 105026 105025 105135 105016 105119 105137 105501 105132 105128 105142 105017 105121 105122 105123 105100 105112 105124 105029 105030 105031 105125 Additional Serial Numbers as of 10/4/23: 143500 |
| Center Classification Date | 20220421 |
| Recall Initiation Date | 20220223 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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