Wfr/aquaplast Corp: Medical Device Recall in 2016 - (Recall #: Z-1264-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: January 7, 2016

Date Posted: April 6, 2016

Recall Number: Z-1264-2016

Event ID: 73543

Reason for Recall:

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.

Status: Terminated

Product Quantity: 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20

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.

Voluntary or Mandated:

Voluntary: Firm initiated