Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1973-2011

Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt...

Medical Positioning Inc / initiated 2010-02-01 / Terminated

Medical Positioning Inc began a recall of 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... 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-1973-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Positioning Inc
Product
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.
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
598959, 599042, 599084, 599091, 599144, 599189, 599225, 599278, 599539, 599593, 599616, 599704, 599706, 599708, 599744, 599847, 599862, 599937, 600018, 600032, 600046, 600106, 600107, 600343, 600428, and 600667 located on the side of the table