Recall Z-1211-2012 ยท LGX Table, Examination, Medical, Powered
Medical Positioning Inc
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.
| Date | Mar 15, 2012 (initiated Mar 5, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.