Reported Apr 6, 2016 · Terminated
Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast…
Wfr/aquaplast Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wfr/aquaplast Corp · 440 Church Rd · Avondale, PA · 19311-9786
Is this the product you have?
- Clear Vue Prone Breast Treatment Table and Access ClearVision
- Prone Breast Device Product UsageClear 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
- Lot codes and dates
- device model numbers
RT-4545CV-17RT-4545CV-20
- device model numbers
- Amount recalled
- 18 units of RT-4545CV-17 and 12 units of RT-4545CV-20
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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