MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is...
Medical Positioning Inc began a recall of MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed... 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-1210-2012
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medical Positioning Inc
- Product
- MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. 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. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo.
- 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
- 4 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 802286, 802303, 802782, and 802722
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