Recall Z-0118-06 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Arcadis Varic Mobile X-Ray System
| Date | Nov 2, 2005 (initiated Aug 1, 2005) |
| Status | Terminated |
| Reason | Screws may become loose and fall into the OR field during surgery. |
| Root cause | Other |
| Action | The recalling firm has their Service Engineers visiting each site to check the screws on the window and secure them with Loctite per Update Instructions SP022/05/S. The Service Engineer is also informing the account of the problem during the visits. |
| Quantity | 24 units |
| Distribution | The products were shipped nationwide to a distributor, a physician, and medical facilities |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042793 | ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Siemens Medi Cal Solutions, Inc., Oct 29, 2004 |