Siemens Medical Solutions USA, Inc recalls Artis Q biplane, Model Number 10848282

Hazard / Issue

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".

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: UDI: 4056869009995; Serial Numbers: 134007 121314 134008 121396 121590 121665 121564 122025 121627 121185 121430 121406 121336 122012 121471 121195 121467 121612 122022 121530 121089 121094 134004 121169 121006 122021 122028 121013 121040 121501 121368 121526 121208 121548 121515 121445 121446 121623 121082 121459 121011 122037 121039 121521 121371 122005 121374 121204 121614 121305 121536 121053 121054 121422 121014 121112 121325 121357 121621 121167 121378 121369 121604 121133 134011 121200 121490 121163 121364 121642 121018 121154 121418 121605 121547 121365 121205 122034 121137 121324 121012 121049 121078 121096 121332 121333 121344 121183 134003 121455 121504 121019 121491 121381 121457 121460 121352 121563 121635 121434 121165 121625 121415 121355 121010 121171 121139 121210 121573 121215 121542 121366 121323 121370 121493 121556 121391 121384 121015 121487 122017 121395 121472 121558 121405 121309 121513 121342 121301 121081 121551 121633 121649 121190 121315 121629 121529 121138 121527 121600 121568 121193 121478 121479 121554 121020 121615 121161 121140 121071 121216 121537 121566 121470 121417 121151 121188 121168 122001 121321 134500 122033 121411 121120 121121 121122 121520 121541 121645 121144 121383 121663 121047 122010 121312 121407 121557 121148 121436 121201 121088 121027 121359 121618 121622 122007 121136 121322 121444 121511 121004 122032 121648 121535 122016 121175 121486 121173 121462 121009 121056 121057 121419 121435 121468 121008 121152 121155 121160 121433 121610 121466 121578 121608 121449 122013 121576 121611 121525 121379 121319 121085 121361 121206 121431 121034 121653 121544 121211 121187 121197 121569 121375 121377 121412 121505 121601 121393 121518 121506 121339 121616 121199 121310 121362 121509 121609 121440 121594 121510 121533 121079 121212 122024 122027 121041 121591 121037 121046 121502 121313 122014 Additional Serial Numbers as of 10/4/23: 134502 121340 121461 121051 121179 121016 121022