Recall Z-2210-2014
Medical Positioning Inc · initiated July 10, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Serial number--802722, 802368, 803147, 804007, 804132, 803195, 802286, 802303, 802782, 803112, 803200, 803274, 803455, 803468, 803883, 803961 and 803960.
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: Component design/selection
Action taken
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.
Details
- Recall number
- Z-2210-2014
- Initiated
- July 10, 2014
- Posted by FDA
- August 13, 2014
- Terminated
- January 3, 2017
- Product code
- LGX – Table, Examination, Medical, Powered
- Quantity
- 17 beds
- 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.
- Recalling firm
- Medical Positioning Inc, Kansas City, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2208-2014 Class II | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | 07/10/2014Terminated |
| Z-2209-2014 Class II | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | 07/10/2014Terminated |
| Z-2211-2014 Class II | Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model #…Excessive weight on the table will cause tables with the affected component to drop into the Trendelenburg… | 07/10/2014Terminated |