Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile
FDA device recall Z-0171-2011 · posted 2010-11-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Units not equipped with protective plastic cover over electronics.
- Action taken
- Siemens Medical Solutions USA, Inc issued a mandatory field update. The letter identified the product, the problem and the action to be taken by the customer. All systems that were not yet equipped with protective cover over the D972 board would be upgraded. For questions regarding this recall call (610) 448-3237.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 177 units
- Distribution
- Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, PA, TX, VA, WA, WI, WY AND PUERTO RICO.
- Date initiated
- 2010-10-04
- Date posted
- 2010-11-01
- 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 |