Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0171-2011

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

Siemens Medical Solutions USA, Inc. / initiated 2010-10-04 / Terminated / root cause: design

Siemens Medical Solutions USA, Inc began a recall of Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile on . The reason FDA records is "Units not equipped with protective plastic cover over electronics". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0171-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Medical Solutions USA, Inc.
Product
Mobilett XP and Mobilett XP Hybrid, Mobile radiology device System, x-ray, mobile
Product code
IZL System, X-Ray, Mobile
Reason for recall
Units not equipped with protective plastic cover over electronics.
Root cause tag
design
FDA root cause
Device Design
Action
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.
Quantity in commerce
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.
Product codes and lots
Model numbers 1818363 and 1818454