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Terminated

Axiom Artis Systems operating with A100 Generator

FDA Recall Z-1237-2010 · Posted 2010-04-05

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeMQB
Date Initiated2010-03-04
Date Terminated2012-07-05
Product Quantity1373 units

Reason for Recall

Due to a contact problem at the low voltage power supply of the generator controller, in rare cases where a user has invoked radiation, it may occur that no radiation is released. Under certain circumstances, radiation is possible by repeated release of the x-ray footswitch or button. To remedy the issue described above, a revised cabling has been installed in all potentially affected syste

Firm Action

The recalling firm issued a Customer Safety Advisory to affected customers via Update Instructions AX006/10/S. The letter informs customers of the potential issues and provides additional information on the implemented resolutions. For additional information, please contact the firm at 888-826-9702.

Root Cause

Nonconforming Material/Component

Distribution Pattern

The product was shipped to medical facilities 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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