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U.S. Department of Health and Human Services

Class 2 Device Recall MPI Rapid Response HUT Table, Model RRHUT 1217

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  Class 2 Device Recall MPI Rapid Response HUT Table, Model RRHUT 1217 see related information
Date Initiated by Firm March 05, 2012
Date Posted March 15, 2012
Recall Status1 Terminated 3 on July 11, 2013
Recall Number Z-1210-2012
Recall Event ID 61348
Product Classification Table, examination, medical, powered - Product Code LGX
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.
Code Information Serial numbers 802286, 802303, 802782, and 802722
Recalling Firm/
Manufacturer		 Medical Positioning Inc
1717 Washington St
Kansas City MO 64108-1121
For Additional Information Contact Joe Hurtig
800-593-3246 Ext. 2356
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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