—#173462

Product

Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

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: 153883 154041 153640 153772 154007 153870 153762 153700 153797 153827 153898 153779 153869 153952 153736 153829 153763 153998 153819 153758 153928 153760 153865 153903 153908 154592 153863 154785 154079 153988 153882 153831 153939 153875 153847 153930 153913 153890 153922 153992 153916 153975 154012 153947 154076 154086 154058 154028 154073 154048 154034 153987 154093 154090 154074 154052 154075 154406 154408 154459 154425 154423 154502 154084 154579 154546 154085 154471 154453 154097 154098 154544 154663 154576 154572 154560 154584 154571 154096 154514 154556 154509 154731 154536 154564 154739 154596 155147 154783 154653 154732 154687 154685 154779 154708 155150 154709 154715 154789 131011 131224 154800 131013 155119 131101 154814 131105 155122 131108 131110 155126 155131 155148 155189 131223 155195 131219 155203 155235 131231

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 #173462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.