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.
This recall has been terminated (originally issued April 13, 2011).
- Company
- Medical Positioning Inc
- Recall Initiated
- February 1, 2010
- Posted
- April 13, 2011
- Terminated
- June 15, 2011
- Recall Number
- Z-1974-2011
- Quantity
- 58 total
- Firm Location
- Kansas City, MO
- Official Source
- View on FDA website ↗
Reason for Recall
The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
Distribution
Worldwide Distribution -- USA, including Puerto Rico, and Canada.
Lot / Code Info
599236, 599457, 599764, 599780,599802, 599845, 599898, 600012, 600047, 600249, 600290, 600304, and 600809 located on the side of the table.
Root Cause
Other
Action Taken
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 jhurtig@medicalpositioning.com 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.