Recall Z-1299-2016 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego 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 | Mar 31, 2016 (initiated Feb 26, 2016) |
| Status | Terminated |
| Reason | In Artis zeego systems, angulations in the vicinity of the C-arm collision area can cause the cable inlet to become clamped and can result in mechanical damage. In Artis systems with A100Plus generators, an attempt to resume operation following detection of a fault (such as a short circuit in the X-ray tube) can result in the failure of a module in the high-voltage generator. |
| Root cause | Device Design |
| Action | The firm, Siemens, sent an "Important Customer Safety Notice" dated 2/16/2016 to its customers. The notice informed them of a corrective action that will be performed to prevent a possible hazard to patients, operators, other persons or equipment. The notice described the product, problem and actions to be taken. Siemens plans to contact each customer to arrange a date to add additional protection mechanisms by means of a system software update. If you have any questions, contact Engineer, Regulatory Technical Specialist at 610-448-6461 or email: Meredith.adams@siemens.com. |
| Quantity | 552 units |
| Distribution | US Nationwide Distribution including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, 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 |