Stryker Australia Pty Ltd — LIFEPAK CR2 Defibrillator
What are the defects?
The LIFEPAK CR2's lid magnet may dislodge from the device. The lid magnet is the primary means by which the device will turn on and off when the lid is opened or closed. If the battery dislodges:
1. The battery may be depleted prematurely, even if the device is not powered on; and
2. Users may not be able to turn the device on if they do not use the on/off button or if the battery has fully depleted.
What are the hazards?
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.
What should consumers do?
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 email@example.com or 0427 540 168.
Authorised Stryker distributors
- 1 January 2017 - 9 March 2021
Therapeutic Goods Administration is the responsible regulator for this recall.