Device product
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.
Z-1264-2016
Product summary
- Event
- Event 73543
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
- Official record key
device-enforcement:Z-1264-2016
Official wording
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.
Code information: device model numbers: RT-4545CV-17, RT-4545CV-20
Distribution pattern: Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
Derived failure modes
-
Unknown
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.