Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2211-2014Class II

Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219

Medical Positioning Inc / initiated 2014-07-10 / Terminated / root cause: design

Medical Positioning Inc began a recall of Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-2211-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Positioning Inc
Product
Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.
Product code
LGX Table, Examination, Medical, Powered
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.
Root cause tag
design
FDA root cause
Component design/selection
Action
Medical 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 commerce
1 bed
Distribution
Worldwide 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.
Product codes and lots
Serial number--803976

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2211-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2208-2014Class IITerminatedVoluntary: Firm initiated
Z-2209-2014Class IITerminatedVoluntary: Firm initiated
Z-2210-2014Class IITerminatedVoluntary: Firm initiated
Z-2211-2014Class IITerminatedVoluntary: Firm initiated