Rapid Response H.U.T. (Head Up Tilt) Table. Model 1017. Powered electrophysiology tilt table. Table can tilt -15 degrees

FDA device recall Z-1973-2011 · posted 2011-04-13 · Terminated

Recall details

Recalling firm

Medical Positioning Inc

Reason for recall

The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.

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.

Root cause

Other

Status

Terminated

Product code

IXR

Quantity affected

58 total

Distribution

Worldwide Distribution -- USA, including Puerto Rico, and Canada.

Date initiated

2010-02-01

Date posted

2011-04-13

Date terminated

2011-06-15

Location

Kansas City, MO