Z-0396-2011

CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop...

Name: Z-0396-2011 CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop...
Creator: Med Tec Inc
Published: 2010-06-21
License: https://open.fda.gov/license/

Medtec LLC / initiated 2010-06-21 / Terminated / root cause: design

FDA source

Med Tec Inc began a recall of 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... on 2010-06-21. The reason FDA records is "Under certain conditions, the extensions can become detached from the main body of the couch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0396-2011
Status: Terminated
Initiated: 2010-06-21
Posted: 2010-11-16
Terminated: 2012-04-17
Recalling firm: Medtec LLC
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.
Product code: IXQ Table, Radiographic, Stationary Top
Reason for recall: Under certain conditions, the extensions can become detached from the main body of the couch.
Root cause tag: design
FDA root 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.
Product codes and lots: Lots M168340 and M167490

Product code IXQ

K973842Class IICarbon Fiber Conformal Couch TopMedtec, Inc. / cleared 1997-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)