ZOLL AED Pro External Defibrillator Recall [Canada]


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ZOLL AED Pro External Defibillator Recall [Canada]

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Canada/Ottawa: ZOLL Medical Corporation, a Chelmsford, Massachusetts establishment, recalls an unknown number of ZOLL AED Pro External Defibrillators due to suspected component malfunction and consequential risk of operational failure and possible death during a cardiac event requiring defibrillation, all serious health hazards.

HCSC: http://ht.ly/gPNK30oXwCG

Direct link: https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70221r-eng.php

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

  • ZOLL AED Pro External Defibrillator, no batch/lot or serial numbers were listed

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

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, a field report was received of the AED Pro prompting “unit failed” during a defibrillation shock attempt. A subsequent investigation traced the problem to an area of an internal circuit board that is susceptible to isolation breakdown.

If the isolation breakdown defect occurs during a defibrillation attempt, the device will issue the “unit failed” message and prevent delivery of the energy to the patient. This will delay or prevent treatment of the person having a Cardiac Arrest or serious Arrhythmia.

If you believe you have purchased or have in your possession any of the recalled AED Pro External Defibrillators, please do not use them. Instead, kindly contact distributor for technical support and/or maintenance for this product. In the meantime, please use a back-up product to provide required protection.

If you have any questions about this recall, please contact ZOLL Medical Corporation toll-free at 1-866-442-1011 or 1-978 421-9655 from 8:30 AM to 6:00 PM 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 Defibrillators, please search for “defibrillators” or more generically, “medical equipment” using the Search Box at the top of this page.

==> To see all recalls and notifications relating to Death hazards, please search for “death” using the Search Box at the top of this page.

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

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More information about this recall:
HCSC ID number: RA-70221
Recalls Direct RIN: 11640-2019
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

We welcome your feedback:
Want to e-mail or share this recall?
==> Simply use the “Share this” options below.
Is this recall relevant to you? Please let us know!
==> Click on the “Like” button below.
E. & O. E.

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