Recall Z-0718-2011 ยท IZL System, X-Ray, Mobile
Siemens Medical Solutions USA, Inc
Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system
| Date | Dec 17, 2010 (initiated Oct 4, 2010) |
| Status | Terminated |
| Reason | battery fuse |
| Root cause | Other |
| Action | SIEMENS released a field update dated October 25, 2010, via SP011/10/S to the representatives. The update described issue and corrective action plan. The representatives are to visit each account to upgrade the systems with a new battery fuse and a new holder. If you have any questions regarding this report, please contact Quality Engineer by phone 610-448-3237 or email: meredith.adams@siemens.com and Director, Product complaints & Field Support by phone 610-448-4634 or email: josephine.mcbride@siemens.com. |
| Quantity | 170 units |
| Distribution | Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033238 | MOBILETTE XP AND MOBILETT XPHYBRID Siemens Medical Systems, Inc., Nov 14, 2003 |