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U.S. Department of Health and Human Services

Class 2 Device Recall Access ClearVue Prone Breast Device

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 Class 2 Device Recall Access ClearVue Prone Breast Devicesee related information
Date Initiated by FirmJanuary 07, 2016
Date PostedMarch 25, 2016
Recall Status1 Terminated 3 on January 06, 2017
Recall NumberZ-1264-2016
Recall Event ID 73543
510(K)NumberK090349 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductClear 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.
Code Information device model numbers: RT-4545CV-17, RT-4545CV-20
FEI Number 1000208827
Recalling Firm/
Manufacturer		 Wfr/aquaplast Corp
440 Church Rd
Avondale PA 19311-9786
For Additional Information ContactNadia Harhen
610-268-0585
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionQfix 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.
Quantity in Commerce18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
DistributionWorldwide Distribution - US Nationwide in the states of NY, PA, CA, IL, and TX. Foreign Countries: Singapore, Australia, Saudi Arabia, and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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