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Terminated

AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System

FDA Recall Z-0144-2011 · Posted 2010-10-26

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2010-09-09
Date Terminated2012-09-29
Product Quantity286 units

Reason for Recall

Sporadic system crash while Perivision is performed.

Firm Action

Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237.

Root Cause

Software design

Distribution Pattern

USA - Nationwide Distribution

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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