Recall Z-0183-2015 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipur
| Date | Nov 7, 2014 (initiated Sep 23, 2014) |
| Status | Terminated |
| Reason | A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routing of the cable may result in increased wear over time. Without additional measures, the potential exists for a cable inside the C-arm to break which could result in restricted functionality or system failure and an ongoing procedure could be terminated. Additionally, a subgroup of affected C-arm systems will receive a replacement of the cable harness. |
| Root cause | Device Design |
| Action | Siemens sent an " Important Safety Information " letter dated September 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Siemens will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. Our service organization will contact with you to schedule an appointment to perform the corrective action. Please feel free to contact our service organization for an earlier appo |
| Quantity | 164 |
| Distribution | Nationwide Distribution including 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 |