Recall Z-0971-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are 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 Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general ang
| Date | Dec 8, 2016 |
| Status | Terminated |
| Reason | Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room. |
| Root cause | Software in the Use Environment |
| Action | Siemens mailed a Customer Safety Advisory Notice (CSAN) dated December 8, 2016, to all affected customers with Customer Safety Advisory Notice AX002/16/S. Additionally, Siemens has initiated a software update via Update Instruction AX001/16/S. Their Service Organization will contact each customer to schedule an appointment to perform the corrective action; however, customers can make contact for an earlier appointment. Customers with questions should call 1-888-826-9702. For questions regarding this recall call 610-448-6461. |
| Quantity | 1,500 distributed Worldwide |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141574 | ARTIS ZEE/ZEEGO SW VC21 Siemens Medical Solutions USA, Inc., Sep 5, 2014 |