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Terminated

Artis zee, Angiographic x-ray system

FDA Recall Z-1824-2017 · Posted 2017-03-30

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2017-03-28
Date Terminated2017-08-07
Product Quantity3 units distributed in U.S.

Reason for Recall

Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.

Firm Action

Siemens mailed a Customer Safety Advisory Notice (CSAN) AX017/17/S to affected customers on 03/28/2017 to inform them of the corrective action that will be performed to prevent a possible hazard to persons and equipment. The notice also explained the underlying issue, the impact on system operation, potential risk to patients and actions they are taking to correct the issue.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to: VA, CA, WI

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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