—#173465

Product

Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: Serial Numbers: 109007 109057 109028 109027 109011 109021 109009 109010 109072 109075 109071 109041 109039 109032 109020 109036 109048 109088 109101 109040 109034 109031 109043 109067 109068 109093 109080 109179 109134 109133 109496 109076 109105 109104 109107 109084 109060 109164 109167 109135 109119 109090 109096 109091 109146 109102 109092 109189 109129 109143 109183 109606 109144 109171 109155 109217 109159 109172 109211 109169 109229 109166 109388 109350 109332 109210 109309 109203 109369 109300 109202 109401 109302 109346 109429 109214 109301 109311 109320 109330 109349 109373 109361 109231 109379 109331 109432 109434 109324 109417 109327 109344 109367 109435 109352 109380 109515 109461 109386 109365 109415 109366 109412 109383 109493 109518 109445 109437 109558 109526 109458 109424 109456 109451 109463 109467 109598 109484 109536 109538 109500 109501 109592 109527 109569 109627 109599 109591 109613 109610 109628

Why it was recalled

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Root cause (FDA determination)

Device Design

Action the firm took

Siemens issued letter dated 6/6/19 advising of the problem, health risk and action to take: .Siemens is implementing a corrective action to all potentially affected users via Update Instruction AX023/18/S. Siemens Service organization will replace the screwed connection of the ceiling support according to specifications / instructions. In the event the bolt connection cannot be replaced due to technical conditions, the complete bearing will be replaced.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2019-06-06
Terminated: 2021-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #173465. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.