Recall Z-1339-2019 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen 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. Procedures that can be performed with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro a
| Date | Apr 9, 2019 |
| Status | Terminated |
| Reason | In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement. |
| Root cause | Software design |
| Action | On April 9, 2019, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that ARTIS systems equipped with certain motor control units may encounter with hardware failure, and planned procedures may need to be terminated and performed on an alternative x-ray system. The firm stated their service organization would contact customers shortly to arrange a date to perform a software update to correct the issue. For an earlier appointment or if you have any questions, you may contact the firm at 1-800-888-7436. Customers were asked to promptly |
| Quantity | 459 (116 US) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL,AR, AZ, CA, FL, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NV, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, VA , WA WI and WV. and Foreign countries. |
| 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 |