Stryker HeartSine Defibrillator Defect Correction Notice
The Stryker HeartSine Defibrillator may potentially be affected by a defect. Please note this is a Defect Correction Notice and not a product recall. The Manufacturer recommends all HeartSine devices are switched on monthly to check for audio voice prompts.
St John is committed to ensuring customer safety and satisfaction. To assist, we have outlined the below steps to follow, as well as Stryker's contact details.
The Stryker HeartSine Defibrillators listed below are subject to a lot-specific Medical Device Product Defect Correction:
- HeartSine 350P
- HeartSine 360P
- HeartSine 500P
A manufacturing-related issue may impair the device's audio prompts. Stryker is issuing a customer notification to remind users to follow the User Manual , and to power the device upon receipt to ensure the audio prompts function as intended.
What you need to do:
- Read Stryker's Defect Correction Notice here.
- Follow Stryker's instructions to power cycle your device.
- Complete and return the User Acknowledgement form to Stryker found on Page 7 of the Urgent Product Defect Correction Notice.
- Communicate the potential defect with your relevant stakeholders.
- Continue to monitor the device and use it as normal. If issues arise, please contact Stryker via postmarketssp@stryker.com.
Stryker appreciates your patience as they work through the large volume of customers impacted by the potential defect.
Distributors such as St John do not have remediated defibrillators available for exchange or purchase.
For more information about the potential product defect, please visit the Stryker website.
Need more help?
If you need any further support with your device, or have questions regarding the defect correction notice, please contact Stryker via the options below:
Phone: +61 2 9170 9162
Email: postmarketssp@stryker.com