Siemens Medical Solutions USA, Inc
ACOM.M angiographic x ray system. Model number 4371741
| Date | Sep 18, 2004 (initiated Jun 16, 2004) |
| Status | Terminated |
| Reason | possible problem reviewing images on the ACOM.M |
| Root cause | Other |
| Action | Strategy: The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions AX026/04/S. The letter informs the customers of the potential problem and provides preventive measures to avoid this occurrence. |
| Quantity | 230 units |
| Distribution | Shipping: The product is shipped to 100 medical facilities in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and 2 government accounts in CA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945293 | TOP ACOM STATION Siemens Medical Solutions USA, Inc., Jan 5, 1995 |