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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Positioning Rapid Response HUT table

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 Class 2 Device Recall Medical Positioning Rapid Response HUT tablesee related information
Date Initiated by FirmJuly 10, 2014
Date PostedAugust 13, 2014
Recall Status1 Terminated 3 on January 03, 2017
Recall NumberZ-2211-2014
Recall Event ID 68763
Product Classification Table, examination, medical, powered - Product Code LGX
ProductMedical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.
Code Information Serial number--803976
Recalling Firm/
Manufacturer		 Medical Positioning Inc
1717 Washington St
Kansas City MO 64108-1121
For Additional Information Contact
816-474-1555
Manufacturer Reason
for Recall		Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg position more rapidly than normal. The product was manufactured with a component that can cause the device to malfunction.
FDA Determined
Cause 2		Component design/selection
ActionMedical Positioning Inc. sent Potential Product Hazard Bulletin letter dated July 8, 2014 to affected customers, via USPS certified return receipt mail. The letter identified the affected product, problem and actions to be taken. Customers were informed a Product Support Specialist will contact them to make arrangements for a Field Service Technician to perform a test designed to identify if the table component affects the table mechanics. If the table is identified as having the affected component, the component will be replaced.
Quantity in Commerce1 bed
DistributionWorldwide Distribution - US Nationwide in the states of CA, GA, FL, IL, IN, KS, KY, MD, MN, MO, MS, NC, NY, OH, TN, TX, VA and WI.
Total Product Life CycleTPLC 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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