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.
Enforcement
- Recall Number
- Z-1264-2016
- Event ID
- 73543
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wfr/aquaplast Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- April 6, 2016
- Initiation Date
- January 7, 2016
- Classification Date
- March 28, 2016
- Termination Date
- January 6, 2017
- Address
- 440 Church Rd, N/A, Avondale, PA, 19311-9786, United States
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.
device model numbers: RT-4545CV-17, RT-4545CV-20
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