Recall Z-1108-04 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
SIEMENS AXIOM Artis - AUTOMAP FUNCTION
| Date | Jul 20, 2004 (initiated Jun 2, 2004) |
| Status | Terminated |
| Reason | Error appears in the AUTOMAP function, Module 2, when PERISTEEPING or PERIVISION is activated simultaneously that causes system to crash. |
| Root cause | Other |
| Action | The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S. |
| Quantity | 127 units |
| Distribution | The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010721 | AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM Siemens Medical Corp., Mar 30, 2001 |