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Terminated

Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392

FDA Recall Z-0708-2018 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeOWB
Date Initiated2017-06-06
Date Terminated2019-05-16

Reason for Recall

Potential for liquid entry

Firm Action

On June 6, 2017, Siemens Healthineers distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via USPS Certified Mail. Siemens conducted a corrective field action in June 2015 to protect the Artis table against liquid entry at critical locations. However, even with this corrective action, if there are larger amounts of liquid on the table surface, they can still enter the table. Siemens Medical Solutions USA, Inc. will contact customers to arrange a date to perform the corrective action. Please feel free to contact the service organization for an earlier appointment by calling 610-448-6461.

Root Cause

Device Design

Distribution Pattern

U.S. Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052202AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEMSiemens Medical Solutions USA, Inc. · 2006-03-07

Official Source

View FDA Recall →

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

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