—#173466

Product

Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

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: 121013 121057 121056 121058 121006 121185 121016 121027 121020 121321 121448 121040 121049 121015 121094 121082 121089 121383 121144 121319 121137 121085 121155 121193 121136 121165 121140 121141 121151 121168 121169 121154 121211 121188 121415 121183 121209 121187 121309 121200 121313 121206 121361 121366 121359 121393 121301 121407 121406 121352 121379 121364 121342 121471 121520 121411 121412 121402 121430 121502 121421 121472 121460 121457 121515 121444 121516 121510 121491 121525 121530 121527

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 #173466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.