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Terminated

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

FDA Recall Z-1721-2009 · Posted 2009-08-20

Recalling FirmMed Tec Inc
Recall StatusTerminated
Product CodeIXQ
Date Initiated2009-03-06
Date Terminated2009-11-05
Product Quantity231 units

Reason for Recall

The silkscreened indexing scale was reversed.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973842CARBON FIBER CONFORMAL COUCH TOPMedtec, Inc. · 1997-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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