Z-1974-2011
Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop...
Medical Positioning Inc / initiated 2010-02-01 / Terminated
Medical Positioning Inc began a recall of Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90... on . The reason FDA records is "The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1974-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Medical Positioning Inc
- Product
- Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
- Product code
- IXR Table, Radiographic, Tilting
- Reason for recall
- The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
- FDA root cause
- Other
- Action
- An undated Urgent - Voluntary Medical Device Product Correction letter was issued on 2/1/2010 by certified mail with return receipt requested. The letter identified the model and serial numbers of the affected product. The consignees were advised to stop using the table immediately and remove it from service until further notice. Customers were to contact Mr. Joe Hurtig at 1-800-593-3246 or [email protected] to confirm receipt of the notice and to provide the firm with the correct contact information. Individualized correction packages including replacement parts and instructions were sent to each consignee. The instructions consisted of (1) Rapid Response HUT Motor Replacement Instructions; (2) Control Box Replacement Instructions; and (3) ILD External Power Supply Removal Instructions.
- Quantity in commerce
- 58 total
- Distribution
- Worldwide Distribution -- USA, including Puerto Rico, and Canada.
- Product codes and lots
- 599236, 599457, 599764, 599780,599802, 599845, 599898, 600012, 600047, 600249, 600290, 600304, and 600809 located on the side of the table.
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