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Recall Observatory FDA recall evidence

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

January 07, 2016

Class II

Product summary

Firm
Wfr/aquaplast Corp
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

    reason.no_named_rule · v1.0.0

    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.