Home / Recalls / Siemens Medical Solutions USA, Inc / Z-2314-2018

Z-2314-2018 Class II Terminated

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

FDA device recall Z-2314-2018 was initiated by Siemens Medical Solutions USA, Inc on May 1, 2018 and is designated Class II. Reason for recall: After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an… The recall status is terminated (terminated May 16, 2019). Affected quantity: 56.

Recall Details

Product Type: Devices
Report Date: Jul 4, 2018
Initiation Date: May 1, 2018
Termination Date: May 16, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56

Product Description

Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.

Reason for Recall

After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Luxembourg, Mexico, Myanmar, Netherlands, New Zealand, Norway, China, Paraguay, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

Code Information

160851 160869 160943 160817 160852 160834 160972 160463 160944 160406 160913 160877 160488 160800 160884 160823 160916 160814 160872 160905 160915 160447 160481 160501 160874 160862 160860 160878 160957 160412 160856 160387 160432 160903 160917 160889 160813 160461 160912 160919 160838 160507 160487 160825 160850 160430 160801 160323 160498 160509 161004 160896 160894 160830 160519 160469

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2314-2018
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

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