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 images for radiation therapy planning.
Recall
- Recall Number
- Z-1264-2016
- Event Number
- 73543
- Firm
- Wfr/aquaplast Corp
- FEI Number
- 1000208827
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- January 7, 2016
- Posted
- March 25, 2016
- Terminated
- January 6, 2017
- Address
- 440 Church Rd, Avondale, PA, 19311-9786
Description
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 images for radiation therapy planning.
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.
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.
Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
18 units of RT-4545CV-17 and 12 units of RT-4545CV-20