Z-1721-2009

Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion

Name: Z-1721-2009 Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion
Creator: Med Tec Inc
Published: 2009-03-06
License: https://open.fda.gov/license/

Medtec LLC / initiated 2009-03-06 / Terminated / root cause: labeling and UDI

FDA source

Med Tec Inc began a recall of Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion on 2009-03-06. The reason FDA records is "The silkscreened indexing scale was reversed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1721-2009
Status: Terminated
Initiated: 2009-03-06
Posted: 2009-08-20
Terminated: 2009-11-05
Recalling firm: Medtec LLC
Product: Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
Product code: IXQ Table, Radiographic, Stationary Top
Reason for recall: The silkscreened indexing scale was reversed.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Med Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a "Recall Notification" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable. Foreign customers were notified by e-mail or phone beginning March 16, 2009. For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.
Quantity in commerce: 231 units
Distribution: Worldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.
Product codes and lots: Lot NNumbers: M055260, M042340, M024020, M022010 and M006980

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)