Recall Z-2302-2020 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging a
| Date | Apr 30, 2020 |
| Status | Terminated |
| Reason | Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthineers issued Urgent Medical Device Correction via AX036/19/S, dated 4/30/20, letter states reason for recall, health risk, and action to take: Siemens will exchange the affected power distributor of the Multi Display Manager. We advise you not to move the Multi Display Manager Container or to open the power distributor before the corrective action can be completed. A service organization will contact you to schedule an appointment to perform the correction via Update Instruction AX035/19/S. Please feel free to contact service organization at 1-800-888-7436 for an earlier app |
| Quantity | 15 US |
| Distribution | US Nationwide distribution. |
| 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 |