| Class 2 Device Recall MPI Rapid Response HUT Table, Model RRHUT 1017 | |
Date Initiated by Firm | March 05, 2012 |
Date Posted | March 15, 2012 |
Recall Status1 |
Terminated 3 on July 11, 2013 |
Recall Number | Z-1211-2012 |
Recall Event ID |
61348 |
Product Classification |
Table, examination, medical, powered - Product Code LGX
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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. |
Code Information |
Serial numbers 802421, 802780, 802781 802783, and 802784 |
Recalling Firm/ Manufacturer |
Medical Positioning Inc 1717 Washington St Kansas City MO 64108-1121
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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 | 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. |
Total Product Life Cycle | TPLC Device Report |
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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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