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Thermography Machines not Authorized to Screen for Breast Cancer
- Starting date:
- November 28, 2012
- Posting date:
- November 28, 2012
- Type of communication:
- Information Update
- Medical Device
- Source of recall:
- Health Canada
- Medical Devices, Important Safety Information
- General Public, Healthcare Professionals
- Identification number:
- What you should do
- Report health or safety concerns
- Related AWRs
- Media enquiries
- Public enquiries
- What Health Canada is doing
OTTAWA – Health Canada is advising Canadians and health care practitioners that no thermography (thermal imaging) machines have been approved to screen for breast cancer in Canada.
Health Canada is not aware of any clinical evidence that thermography can be used effectively as a screening technique for the early detection of breast cancer. As such, it may present a potential risk to women relying on the results.
Health Canada would also like to remind consumers that thermography machines are not a replacement for routine monitoring and screening for breast cancer.
What you should do
Patients who have relied on these types of machines for breast cancer screening should contact their physician for appropriate follow-up and testing.
Report health or safety concerns
Complaints involving thermography machines used in the screening of breast cancer can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
What Health Canada is doing
The Department is following-up with the manufacturers of these devices to help ensure they are aware that it is illegal to advertise or sell these types of machines to screen for breast cancer in Canada. This could result in a stop sale of any unlicensed product. Health Canada is also working with the Canada Border Services Agency to stop any unlicenced devices from entering Canada.
Health Canada will be communicating with the provincial and territorial ministries of health to advise them that clinics falling under their responsibility should not be promoting or using these devices to screen for breast cancer.
For more information
There is more information on breast cancer, available through the Public Health Agency of Canada at http://www.phac-aspc.gc.ca/cd-mc/cancer/breast_cancer-cancer_du_sein-eng.php. To confirm whether a device is licensed in Canada, please refer to the Medical Devices Active Licence Listing at www.mdall.ca.
- Date modified: