Canon Ultimax-i Medical Imaging Device Recall [Canada]

Click to enlarge image

Canada/Ottawa: Canon Medical Systems Canada, a Markham, Ontario establishment, a subsidiary of Canon Medical Systems Corporation of Otawara-shi, Tochigi, Japan, recalls an unknown number of Ultimax-i Medical Imaging Devices from the Canadian marketplace due to suspected imaging inconsistencies and consequential incorrect patient diagnostics, potential treatment delays and poor patient outcomes, all serious health and safety hazards.

HCSC: http://ht.ly/agBT30qTR5i

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2020/73299r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following medical devices are subject to this recall:

• Ultimax-i Medical Imaging Devices, sold with a batch/lot of K2H2012032 and a model/catalog number of 813181

Please consult the photograph above for details of the product’s design and retail presentation.

==> No barcodes, UPCs, item numbers, best-before date codes, manufacturing date codes, production dates, expiry dates, regulatory approval designations, registration numbers, agency approval designations or other identification numbers were listed with this recall notification.

According to Health Canada, Canon Medical Systems has recalled an unknown number of Ultimax-i Medical Imaging Devices from the Canadian marketplace due to suspected imaging inconsistencies.

If you believe you have purchased or have in your possession any of these recalled Medical Imaging Devices, please do not use them for diagnostic imaging. Instead, kindly contact your Canon Medical Systems sales or support representative for problem determination and corrective measures, as necessary.

If you have any further questions, comments or complaints about this recall, please contact Canon Medical Systems Canada toll-free at 1-800-667-2671 (for English) or toll-free 1-877 208-3324 (for French) during normal business hours, Eastern Standard Time, Monday to Friday.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous medical imaging equipment, please search for “medical imaging” or more generically, “medical” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Canon Medical Systems Canada, please search for “Canon” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-73299
Recalls Direct RIN: 13184-2020
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe product you purchased in Canada [external: new window opens]:
==> http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/index-eng.php
Search for a recalled product on the Health Canada Web site [external: new window opens]:
==> http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

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E. & O. E.

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