Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1211-2012

MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical Positioning Inc...

Medical Positioning Inc / initiated 2012-03-05 / Terminated / root cause: labeling and UDI

Medical Positioning Inc began a recall of MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed for multiple uses including... on . The reason FDA records is "The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1211-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Positioning Inc
Product
MPI Rapid Response HUT Table, Model #RRHUT 1017. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures.
Product code
LGX Table, Examination, Medical, Powered
Reason for recall
The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power.
Root cause tag
labeling and UDI
FDA root cause
Error in labeling
Action
Medical Positioning Inc. sent a "RAPID RESPONSE HUT TABLE LABELING CORRECTION NOTIFICATION" letter dated March 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included an Owner's Manual insert page which clearly states the warning and how to avoid the electric shock hazard and a warning tag to attach to the product's power cord near the plug end using the provided wire tie. Contact the firm at 816-595-2356 for questions regarding this notice.
Quantity in commerce
5 tables
Distribution
Worldwide Distribution-USA (nationwide) including the states of IN, KS, WI, NY, IL, NC, OH, and MS and the country of Thailand.
Product codes and lots
Serial numbers 802421, 802780, 802781 802783, and 802784