Recall Z-2367-2019 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee and Artis Q/ Q.zen Interventional Fluoroscopic X-Ray System with patient tables as follows: Systems Material Number Artis zee biplane 10094141; Artis Q floor 10848280; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen biplane 10848355; Artis zee ceiling 10094137; Artis Q ceiling 10848281; Artis Q zeego
| Date | Jul 30, 2019 |
| Status | Terminated |
| Reason | Artis zee/Q systems patient tables may potentially have cracks in the table mainframe, and cause mechanical detachment of the upper part of the patient bed and lead to hazardous situations for patients and medical personnel due to falling parts |
| Root cause | Process control |
| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice (AX011/19/S) on 8/1/19 a . The letter identifies the reason for recall, health risk and action to take: Siemens Service organization will inspect the table mainframe for possible cracks and will contact you shortly to arrange a date to perform this corrective action. Contact the service organization for an earlier appointment at 1-800-888-7436. |
| Quantity | US 17 |
| Distribution | US Nationwide Distribution - AL, AR, KS, MI, MN, NC, ND, NY, OH, SC, TX, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181407 | Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc., Aug 15, 2018 |