Recalls / —
—#95820
Product
Mobilett XP Hybrid/Digital/CR Intended use: mobile x-ray system
- FDA product code
- IZL — System, X-Ray, Mobile
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K033238
- Affected lot / code info
- Model numbers 1818454, 1818447, and 1818959
Why it was recalled
battery fuse
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355
Distribution
- Distribution pattern
- Nationwide distribution: AZ, CA, DC, MD, PA, SC and VA.
Timeline
- Recall initiated
- 2010-10-04
- Posted by FDA
- 2010-12-17
- Terminated
- 2012-09-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #95820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.