Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017
Medical Positioning Inc began a recall of Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. 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-2208-2014
- 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 # 1017. 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
- 20 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.
- Product codes and lots
- Serial number--802971, 803106, 803356, 803588, 803616, 803854, 802781, 802783, 802780, 802784, 802421, 802861, 802939, 802949, 802924, 803867, 803926, 802809 and 804118.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2208-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2209-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2210-2014 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2211-2014 | Class II | Terminated | Voluntary: Firm initiated |
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