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Thermography Machines not Authorized to Screen for Breast Cancer

Report a Concern
Starting date:
November 28, 2012
Posting date:
November 28, 2012
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices, Important Safety Information
Audience:
General Public, Healthcare Professionals
Identification number:
RA-15920

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
Health Canada
Address Locator: 2003D
Ottawa, Ontario K1A 0K9


Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709

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.