LIFEPAK CR2 Defibrillator

Official notice

22 Apr 2021

Last checked

22 Apr 2021

High riskACCC

An official ACCC notice concerns LIFEPAK CR2 Defibrillator. If the battery has been depleted or users do not turn the device on, the device will not work and will not be available to defibrillate a patient in an emergency. Published 2021-04-22.

What to do now

Stryker is contacting all customers to provide Supplemental Instructions and replacement accessories, where needed. Affected consumers are advised to perform the following for all LIFEPAK CR2 Defibrillators: 1. Inspect the defibrillator and record the item and serial number of the device on the customer response form. 2. Review and retain the Supplemental Instructions attached to the customer letter. 3. Inspect the lid for the presence of a magnet as per the instructions in the customer letter. 4. Conduct a Device Readiness check in accordance with the LIFEPAK CR2 Operating Instructions, maintaining a State of Readiness (pp. 77-78), and the Supplemental Instructions provided with the customer letter. 5. Return the customer response form to Stryker or a distributor, indicating the results of these inspections and checks. If consumers have a device which does not turn on when the lid is opened, they can continue to use it by using its power button to turn it on and off and follow the updated operating instructions. For further information, consumers can contact the Stryker Post Market Team on postmarketssp@stryker.com or 0427 540 168.

Recall number

9f9cd737-0210-4a7d-9cfb-cac12e7348fb

Official notice

2021-04-22

The hazard

If the battery has been depleted or users do not turn the device on, the device will not work and will not be available to defibrillate a patient in an emergency.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

282772

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Affected products

Product 1

LIFEPAK CR2 defibrillators are automated external defibrillators (AEDs) used in cases of life-threatening irregular heartbeat that leads to Sudden Cardiac Arrest (SCA) ARTG 282772 (Stryker Australia Pty Ltd - Non-rechargeable public automated external defibrillator)

Risk / hazard

If the battery has been depleted or users do not turn the device on, the device will not work and will not be available to defibrillate a patient in an emergency.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

9f9cd737-0210-4a7d-9cfb-cac12e7348fb

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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