Recall Z-1945-2013 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Siemens AXIOM Artis zeego x-ray, angiographic system
| Date | Aug 9, 2013 (initiated May 13, 2013) |
| Status | Terminated |
| Reason | Siemens issued a customer safety notice about the overlay of system information after a functional check of the brakes on the Artis Zeego system. |
| Root cause | Software design |
| Action | The firm, Siemens, sent an "Important safety notice" by letter on May 13, 2013 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to immediately notify the service department to clarify what further measures need to be taken, if after carrying out the regular brake test, the system can only be moved at a reduced speed. If this device has been sold and is therefore no longer in your possession, send this safety notice to the new owner and provide the new owner to Siemens. Update instruction AX012/13/S was issued, and a software |
| Quantity | 132 |
| Distribution | Nationwide distribution: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MD, MN, MO,MS, NC, NE, NH, NJ, NY, OH, PA, PR, SD, TN, TX, UT, VA, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 Siemens Medical Solutions USA, Inc., Jun 18, 2009 |