Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobilett XP and Mobilett XP Hybrid are radiographic s
FDA device recall Z-1985-2014 · posted 2014-07-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
- Action taken
- Siemens sent a Safety Advisory Notice letter dated May 9, 2014, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that a Siemens service technician would be visiting their site to identify and service affected devices.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 10
- Distribution
- US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.
- Date initiated
- 2014-05-09
- Date posted
- 2014-07-02
- Date terminated
- 2014-12-15
- 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 |