Recall Z-0124-2010 ยท IYE Accelerator, Linear, Medical
Med Tec Inc
CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.
| Date | Nov 6, 2009 (initiated Aug 31, 2009) |
| Status | Terminated |
| Reason | Some of the packages contain the incorrect mask style. |
| Root cause | Process control |
| Action | The recalling firm initiated their recall via letter dated 8/27/09 issued certified mail for the domestic customers and e-mail for the foreign customer. The communication informs the customer of the reason for recall and offers to replace the product. For questions or for return of the mask, a phone number is provided. A response form was enclosed with the letter for completion to indicate the amount of affected product in the possession of the customer and whether or not they plan to return it. |
| Quantity | 12 boxes |
| Distribution | Worldwide Distribution -- USA, including states of FL, TX, and OH and country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM Medtec, Inc., Jul 18, 1994 |