Recall Z-2313-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
| Date | May 1, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | On May 1, 2018, the firm notified customers via Urgent Medical Device Correction letters. Users were warned that the Large Display may not show an image after it returns from power save mode. The Large Display stays black without showing an error message although X-Ray is still possible. The problem occurs sporadically, and does not occur during an ongoing procedure. The firm stated that there should be no influence on the previous treatment of patients. Users were instructed to follow standard emergency procedures in the event of system failures. It is recommended to consider reinforcing em |
| Quantity | 1 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141574 | ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc., Sep 5, 2014 |