Recall Z-0508-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
| Date | Aug 24, 2017 |
| Status | Terminated |
| Reason | Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards. |
| Root cause | Employee error |
| Action | Siemens sent an Urgent: Medical Device Correction letter dated August 24, 2017 to all affected customers. The letter identified the affected product, problem and actions to be taken. A local management or dispatch will schedule for an inspection to correct the issue. For questions please call 1-800-888-7436 |
| Quantity | 265 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |