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Terminated

Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems

FDA Recall Z-0485-2010 · Posted 2009-12-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2009-10-26
Date Terminated2010-01-26
Product Quantity11 units

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.

K073290ARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc. · 2008-02-11

Official Source

View FDA Recall →

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

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