Recall Z-0710-2018 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
| Date | Sep 28, 2017 |
| Status | Terminated |
| Reason | The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible. |
| Root cause | Device Design |
| Action | Letters were sent to all consignees with instructions to contact their service provider to arrange for an appointment to update the device hardware. |
| Quantity | 510 |
| Distribution | Distributed in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073290 | ARTIS ZEE AND ZEEGO Siemens Medical Solutions USA, Inc., Feb 11, 2008 |
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 Siemens Medical Solutions USA, Inc., Jun 18, 2009 |
| K122644 | ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 Siemens Medical Solutions USA, Inc., May 16, 2013 |
| K141574 | ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc., Sep 5, 2014 |