Recall Z-1721-2009 ยท IXQ Table, Radiographic, Stationary Top
Med Tec Inc
Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
| Date | Aug 20, 2009 (initiated Mar 6, 2009) |
| Status | Terminated |
| Reason | The silkscreened indexing scale was reversed. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973842 | CARBON FIBER CONFORMAL COUCH TOP Medtec, Inc., Dec 5, 1997 |