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Terminated

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.

FDA Recall Z-1974-2011 · Posted 2011-04-13

Recall StatusTerminated
Product CodeIXR
Date Initiated2010-02-01
Date Terminated2011-06-15
Product Quantity58 total

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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