Recall Z-0796-05 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
Axiom Artis X-Ray System using software version VB11D or VB20B
| Date | May 3, 2005 (initiated Apr 11, 2005) |
| Status | Terminated |
| Reason | Live display in exam room may sporadically stop working although the display in the control room remains fully operational |
| Root cause | Other |
| Action | The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts. |
| Quantity | 295 units |
| Distribution | The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV. |
| 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 |