Home / Recalls / Siemens Medical Solutions USA, Inc / Z-2313-2018

Z-2313-2018 Class II Terminated

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

FDA device recall Z-2313-2018 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: 1.

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: 1

Product Description

Artis zee MP, Material no. 10094139, 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

157707

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2313-2018
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.