Recall Z-1264-2016— Wfr/aquaplast Corp

Name: FDA recall Z-1264-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-07

Class II · Terminated

Class II FDA medical device recall by Wfr/aquaplast Corp, initiated 2016-01-07, terminated 2017-01-06. It names one FDA 510(k) clearance: K090349. 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.. 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..

Recalling firm: Wfr/aquaplast Corp
Classification: Class II
Status: Terminated
Initiated: 2016-01-07
Terminated: 2017-01-06
Firm location: Avondale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K090349 — CLEARVUE PRONE BREAST TREATMENT TABLEOrbital Therapy, LLC·cleared 2009-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.