Recall Z-2233-2010 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.
| Date | Aug 16, 2010 (initiated Jul 13, 2010) |
| Status | Terminated |
| Reason | The Axiom Artis MP, Artis dMP or Artis zee Multipurpose C-arm gearbox can become damaged. If the gearbox is damaged, the C-arm may tilt away when being repositioned and collide with nearby objects in its range of motion. |
| Root cause | Other |
| Action | Siemens has issued an "Urgent Field Safety Notice: Customer Safety Information to consignees with Update Instructions AX033/10/S. This letter informed customers of the issue, and provides an Addendum to the User Manual. The Update Instructions describe the process for installation of an additional clamping mechanism provided by Siemens into the existing system, which will be activated if the gearbox is damaged. If activated, the clamping machanism will prevent the C-arm from tilting away, stop regular operation, and alert the operator to check the system and repair the gearbox damage. |
| Quantity | 131 units |
| Distribution | Nationwide distribution: States of AL, AZ, CA, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA, WA, WI, and WY. |
| FDA record | Open on fda.gov |