Siemens Medical Solutions USA, Inc Recall 89860
Description: Artis zee floor MN, Model Number 10094142
Siemens Medical Solutions USA, Inc Recall 89860 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0971-2022 |
| Event ID | 89860 |
| Event Description | Artis zee floor MN, Model Number 10094142 |
| Product Type | Devices |
| Distribution | US Nationwide. |
| Quantity | 24 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: 4056869010090; Serial Numbers: 140421 140115 140101 140205 140213 140204 140209 140219 140224 140218 140226 140221 140220 140206 140105 140423 140406 140422 140102 140214 140109 140202 140424 140114 |
| Center Classification Date | 20220421 |
| Recall Initiation Date | 20220223 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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