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Breastlight is not Authorized for Use as a Screening Device for the Detection of Breast Cancer
- Starting date:
- November 12, 2010
- Posting date:
- November 12, 2010
- Type of communication:
- Information Update
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public
- Identification number:
- RA-110003939
Health Canada is informing Canadians that PWB Health Ltd. (the "Company") is recalling its Breastlight product, which is currently available on the Canadian market. PWB Health Ltd. is requesting that pharmacies and other distributors immediately stop sale of this product.
Reason
This recall comes as a result of Health Canada's evaluation of the safety and effectiveness information regarding this new technology.
Affected products
Breastlight
Product description
Breastlight is marketed as a new health and well-being product for women, to aid in noticing changes in their breasts over time and as a component of a woman's "breast awareness", according to the Company.
Hazard identified
It is important to note that there is no clinical evidence that the Breastlight can be used effectively as a screening device for the early detection of breast cancer. As such, it may present a potential risk to women relying on it for early detection of breast cancer.
Media enquiries
Health Canada
613-957-2983
Public enquiries
613-957-2991
1-866-225-0709
What Health Canada is doing
Health Canada will monitor the company's recall and will inform Canadians and take appropriate action if new safety information arises. Health Canada is also working with the Canada Border Services Agency to stop the importation of any shipments of Breastlight from entering Canada.
Health Canada is reminding consumers that Breastlight is not a replacement for routine monitoring and screening for breast cancer. Patients who have relied on this product for breast cancer screening should contact their physician for appropriate follow-up and testing.