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Terminated

Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354

FDA Recall Z-1903-2019 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2019-06-06
Date Terminated2021-02-09
Product Quantity15

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181407Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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