Z-1264-2016 Class II Terminated
FDA device recall Z-1264-2016 was initiated by Wfr/aquaplast Corp on January 7, 2016 and is designated Class II. 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 differen… The recall status is terminated (terminated January 6, 2017). Affected quantity: 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- January 7, 2016
- Termination Date
- January 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
Code Information
device model numbers: RT-4545CV-17, RT-4545CV-20