—#161467

Product

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

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052202
Affected lot / code info: 10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392

Why it was recalled

Potential for liquid entry

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: U.S. Nationwide

Timeline

Recall initiated: 2017-06-06
Terminated: 2019-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161467. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.