Open, Classified

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

FDA Recall Z-0956-2023 · Posted 2023-01-13

Recalling FirmSiemens Medical Solutions USA, Inc

Recall StatusOpen, Classified

Product CodeOWB

Date Initiated2022-12-16

Product Quantity550 units

Reason for Recall

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

Firm Action

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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K190768ARTIS iconoSiemens Medical Solutions USA, Inc. · 2019-09-12 K163286ARTIS phenoSiemens Medical Solution USA, Inc. · 2017-03-09

Official Source

View FDA Recall →

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