Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system
FDA device recall Z-0718-2011 · posted 2010-12-17 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- battery fuse
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 170 units
- Distribution
- Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA.
- Date initiated
- 2010-10-04
- Date posted
- 2010-12-17
- Date terminated
- 2012-09-29
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBILETTE XP AND MOBILETT XPHYBRID (K033238) | Siemens Medical Systems, Inc. | 2003-11-14 |