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Terminated

Axiom Artis systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malvern, PA 19355. Intended for x-ray, angiographic use.

FDA Recall Z-1732-2010 · Posted 2010-05-28

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-04-12
Date Terminated2013-04-11
Product Quantity83 units

Reason for Recall

sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.

Firm Action

Siemens issued an "Urgent Field Safety Notice" to consignees describing the affected device instructing users to contact the recalling firm's service organization to schedule maintenance. For further information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-3237.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021021MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTISSiemens Medical Solutions USA, Inc. · 2002-06-06

Official Source

View FDA Recall →

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

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