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Terminated

ARTIS Q, Interventional Fluroscopic x-ray system

FDA Recall Z-1534-2017 · Posted 2017-03-19

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-02-22
Date Terminated2017-10-24
Product Quantity264 distributed worldwide (112 in the U.S.)

Reason for Recall

In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

Firm Action

A Customer Safety Advisory Notice (CSAN) was mailed on 02/22/2017 to customers affected by the issue on 02/22/2017 to inform them of the corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the impact on system operation and the potential risk to patients. It also informed users of the actions being taken and how they will be implemented.

Root Cause

Other

Distribution Pattern

Distributed throughout the United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123529ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc. · 2013-02-26

Official Source

View FDA Recall →

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

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