Recall Z-1608-2008 ยท IYE Accelerator, Linear, Medical
Civco Medical Instruments Inc
MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.
| Date | May 21, 2008 (initiated Feb 25, 2008) |
| Status | Terminated |
| Reason | Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct. |
| Root cause | Labeling mix-ups |
| Action | Consignees were notified by a Recall Notification letter on 2/25/08. The letter informed users that the recalling firm will replace the affected product. It also requested that users return a recall notification acknowledging notification of recall. Users were instructed to contact their sales representative to arrange servicing or for additional information at 1-800-842-8688. |
| Quantity | 160 |
| Distribution | Worldwide Distribution including USA states of IL, PA, NC, TN, SD, CA, MI, WI, MA, and CO; and country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.