Home / Recalls / Siemens Medical Solutions USA, Inc / Z-2308-2018

Z-2308-2018 Class II Terminated

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

FDA device recall Z-2308-2018 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: 68.

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: 68

Product Description

Artis zee biplane, Material no. 10094141, 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

153992 154616 154551 154536 154096 154532 154157 154571 154074 154012 154612 153274 154090 154567 154480 154093 154502 154408 153987 154509 154079 154462 154098 154073 154076 153959 154653 154671 154556 153869 154633 154058 154155 154453 154579 154034 154560 154596 153708 153248 154048 153903 153819 154087 154606 154604 154581 154423 154546 154052 154501 154514 154562 154056 153999 154631 154089 154476 131020 154584 154610 153607 153886 154576 154602 154572 154564 153744

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2308-2018
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.