FDA Enforcement Class II Terminated

Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.

Recall: Z-2210-2014 · Reported August 20, 2014

Enforcement

Recall Number
Z-2210-2014
Event ID
68763
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Medical Positioning Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
August 20, 2014
Initiation Date
July 10, 2014
Classification Date
August 13, 2014
Termination Date
January 3, 2017
Address
1717 Washington St, N/A, Kansas City, MO, 64108-1121, United States

Description

Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.

Reason

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.

Code Info

Serial number--802722, 802368, 803147, 804007, 804132, 803195, 802286, 802303, 802782, 803112, 803200, 803274, 803455, 803468, 803883, 803961 and 803960.

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.

Quantity

17 beds