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

FDA device recall Z-0396-2011 · posted 2010-11-16 · Terminated

Recall details

Recalling firm

Med Tec Inc

Reason for recall

Under certain conditions, the extensions can become detached from the main body of the couch.

Action taken

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

Root cause

Device Design

Status

Terminated

Product code

IXQ

Quantity affected

5 extensions

Distribution

Worldwide distribution: USA including states of: CA, FL, IA OH, and WI; and countires of: United Kingdom, Australia, and Switzerland.

Date initiated

2010-06-21

Date posted

2010-11-16

Date terminated

2012-04-17

Location

Orange City, IA

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