Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
Recall
- Recall Number
- Z-1973-2011
- Event Number
- 58035
- Firm
- Medical Positioning Inc
- FEI Number
- 1000118382
- Product Code
- IXR
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 1, 2010
- Posted
- April 13, 2011
- Terminated
- June 15, 2011
- Address
- 1717 Washington St, Kansas City, MO, 64108-1121
Description
Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.
The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
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.
Worldwide Distribution -- USA, including Puerto Rico, and Canada.
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