Recalls / —

—#94926

Product

Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile

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 1818363 and 1818454

Why it was recalled

Units not equipped with protective plastic cover over electronics.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2010-10-04

Posted by FDA

2010-11-01

Terminated

2012-09-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #94926. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.