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U.S. Department of Health and Human Services

Class 2 Device Recall Rapid Response HUT Table

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  Class 2 Device Recall Rapid Response HUT Table see related information
Date Initiated by Firm February 01, 2010
Date Posted April 13, 2011
Recall Status1 Terminated 3 on June 15, 2011
Recall Number Z-1975-2011
Recall Event ID 58035
Product Classification Tilting Radiologic Table - Product Code IXR
Product Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Medical Positioning Incorporated. 800-593-3246.

Used in clinical and hospital settings by trained radiologists.
Code Information 598972, 599406, 599650, 599707, 599710, 599721, 599771, 599870, 599871, 599964, 600024, 600115, 600333, 600550, 600551, 600655, and 600790 located on the side of the table
Recalling Firm/
Manufacturer		 Medical Positioning Inc
1717 Washington St
Kansas City MO 64108-1121
For Additional Information Contact Joseph J. Hurtig
816-474-1555
Manufacturer Reason
for Recall		 The tilt tables work intermittently and some have become stuck in an inclined or reclined position during procedures.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 58 total
Distribution Worldwide Distribution -- USA, including Puerto Rico, and Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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