Class 2 Device Recall CIVCO Posifix Extension

• Date Initiated by Firm: June 21, 2010
• Date Posted: November 16, 2010
• Recall Status: Terminated on April 17, 2012
• Recall Number: Z-0396-2011
• Recall Event ID: 55999
• 510(K)Number: K973842
• Product Classification: Table, radiographic, stationary top - Product Code IXQ
• Product: CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA.; ; For use to support and aid in positioning a patient during radiologic and other medical procedures.
• Code Information: Lots M168340 and M167490
• Recalling Firm/ Manufacturer: Med Tec Inc; 1401 8th St; PO Box 320; Orange City IA 51041-0320
• For Additional Information Contact: James Leong; 319-656-4447 Ext. 224
• Manufacturer Reason for Recall: Under certain conditions, the extensions can become detached from the main body of the couch.
• FDA Determined Cause: Device Design
• Action: The recalling firm, CIVCO, issued an 'Urgent Field Safety Notice" dated June 15, 2010, via overnight mail on June 21, 2010, regarding the first issue for the three extension models. The letter described the product, problem, and actions to be taken by the customers. The customers were instructed to load the patients on the couch from the bottom of the couch and not from the superior end with the extension and do not let patients crawl to the top of the couch with their full upper body weight at the end of the couch; notify others within their organization that may have the extension, and complete and return the enclosed response form via fax: Attention: CIVCO MTL6600 Rectangular Extension at 877-271-2310. The letter informs the customer that they will be receiving a kit to replace the locking tab so that the extension will be less likely to come loose. Once the kit is received, the customers are ask to return the replaced part and sign a confirmation form for their records. CIVCO sent a second "Urgent Field Safety Notice" dated July 20, 2010 via overnight mail on July 21, 2010, and by phone on July 22, 2010, regarding the second issue which covered only MTIL6600 regarding the weight being dropped onto the corner of the rectangular extension. The letter described the product, problem and action to be taken by the customers. The customers were instructed to accept a one-piece Universal Couch Top replacement; sign the attached form stating the they will stop using the rectangular extension and return it to CIVCO or sign the form stating they have been advised of the recall and they will exercise the necessary precautions to prevent the event from occurring by always using the thumb screw lock and never allowing the patient to crawl on the couch top or extension, and to notify others within their organization that have the extension. The customer was informed that their current system would be replaced and sent back to the recalling firm. Please contac
• Quantity in Commerce: 5 extensions
• Distribution: Worldwide distribution: USA including states of: CA, FL, IA OH, and WI; and countires of: United Kingdom, Australia, and Switzerland.
• 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.

• 510(K) Database: 510(K)s with Product Code = IXQ and Original Applicant = MEDTEC, INC.