Recalls / —

—#197571

Product

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

FDA product code

OWB — Interventional Fluoroscopic X-Ray System

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K163286, K190768

Affected lot / code info

1) ARTIS pheno; Material #10849000; UDI/DI: 4056869046877 2) ARTIS icono biplane; Material #11327600; UDI/DI: 4056869063317 3) ARTIS icono floor; Material #11327700; UDI/DI: 4056869149325

Why it was recalled

Mechanical connection between the tabletop and table base may be lost.

Root cause (FDA determination)

Device Design

Action the firm took

A customer letter dated 12/16/2022 was issued to affected consignees. Consignees are advised the following: -Before treatment is started, check if both transversal guide rails and the roller bearing at the end of each rail are in the correct position. -For the affected OR tables, an inspection including installation of a safety measure will be carried out. Siemens is currently developing this mitigation. Once correction is available, the service department will contact the consignees to arrange a date to perform the corrective action. Consignees are requested to acknowledge the recall letter and return the acknowledgement form to Siemens promptly.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Italy, Japan, Kazakhstan, Kuwait, Lebanon, Monaco, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.

Timeline

Recall initiated

2022-12-16

Posted by FDA

2023-01-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #197571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.