Z-0956-2023 Class II Ongoing

Recalled by Siemens Medical Solutions USA, Inc — Malvern, PA

FDA device recall Z-0956-2023 was initiated by Siemens Medical Solutions USA, Inc on Dec 16, 2022 and is designated Class II. Reason for recall: Mechanical connection between the tabletop and table base may be lost. The recall status is ongoing. Affected quantity: 550 units.

Recall Details

Product Type
Devices
Report Date
Jan 25, 2023
Initiation Date
Dec 16, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
550 units

Product Description

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Reason for Recall

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

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.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0956-2023
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.