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.
FDA Recall Z-1264-2016 · Posted 2016-03-25
Recalling FirmWfr/aquaplast Corp
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-01-07
Date Terminated2017-01-06
Product Quantity18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.