Recall Z-0396-2011 ยท IXQ Table, Radiographic, Stationary Top
Med Tec Inc
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.
| Date | Nov 16, 2010 (initiated Jun 21, 2010) |
| Status | Terminated |
| Reason | Under certain conditions, the extensions can become detached from the main body of the couch. |
| 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 com |
| Quantity | 5 extensions |
| Distribution | Worldwide distribution: USA including states of: CA, FL, IA OH, and WI; and countires of: United Kingdom, Australia, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973842 | CARBON FIBER CONFORMAL COUCH TOP Medtec, Inc., Dec 5, 1997 |