Recall Z-1264-2016 ยท IYE Accelerator, Linear, Medical
Wfr/aquaplast Corp
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear accelerator radiation therapy. It may be used with CT and MR scanners to acquire ima
| Date | Mar 25, 2016 (initiated Jan 7, 2016) |
| Status | Terminated |
| Reason | Some of the Access ClearVue Prone Breast devices may contain scales that are misaligned from the zero reference with respect to other Access ClearVue Prone Breast devices. This can result in differences in scale orientation. |
| Root cause | Process control |
| Action | Qfix sent a Field Safety Notification letter dated January 7, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Inventory Survey form and mail it back. For questions call (610) 268-0585. |
| Quantity | 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20 |
| Distribution | Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090349 | CLEARVUE PRONE BREAST TREATMENT TABLE Orbital Therapy, LLC, Mar 9, 2009 |