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