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Siemens Medical Solutions USA, Inc Recall 89860

Description: Artis Q floor, Model Number 10848280

Siemens Medical Solutions USA, Inc Recall 89860 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0974-2022
Event ID89860
Event DescriptionArtis Q floor, Model Number 10848280
Product TypeDevices
DistributionUS Nationwide.
Quantity64 systems
Recall ReasonIf 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 Classification20220427
Device Code InfoUDI: 4056869009971; Serial Numbers: 103221 103217 103218 103345 103409 103340 103439 104007 103302 103232 104016 104005 103391 103404 104027 132002 103334 103354 103359 103030 103335 104012 103220 103013 103384 103035 104029 104020 103039 103050 103365 103279 104025 103285 103286 103207 103222 103230 103295 103310 103430 103432 104047 103001 103239 103353 104013 103444 132502 132500 103048 103315 103263 103356 132000 103028 103241 103293 103388 103389 132003 103245 103348 103253
Center Classification Date20220421
Recall Initiation Date20220223
Recalling FirmSiemens Medical Solutions USA, Inc
Initial Notification Letter
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