—#173474

Product

Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163286
Affected lot / code info: Serial Numbers: 164021 164053 164055 164054 164088 164140 164113 164069

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 #173474. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.