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Terminated

Axiom Artis dMP, Model number 7555365 angiographic x-ray systems

FDA Recall Z-0484-2010 · Posted 2009-12-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2009-10-26
Date Terminated2010-01-26
Product Quantity32 unit

Reason for Recall

c-arm may tilt

Firm Action

The firm has issued a Customer Safety Advisory Notice via Update Instructions AX051/09/S to affected customers. This letter informs customers of the potential malfunction and of the possible danger to patients, users or other persons.

Root Cause

Other

Distribution Pattern

Nationwide

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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