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VOLUNTARY RECALL - Heartsine SAM 350P & SAM 450P

MEDAIRE IS COMMITTED TO ENSURING THE SAFETY AND WELL-BEING OF OUR CLIENTS. WE ARE AWARE OF A VOLUNTARY RECALL INITIATED BY STRYKER CONCERNING SPECIFIC HEARTSINE SAMARITAN PAD MODELS: SAM 350P, SAM 360P, AND SAM 450P. THIS RECALL IS DUE TO A POTENTIAL DEVICE MALFUNCTION ISSUE IDENTIFIED DURING QUALITY TESTING. THIS ARTICLE PROVIDES ESSENTIAL INFORMATION AND RECOMMENDATIONS FOR CLIENTS WHO MAY BE AFFECTED BY THIS RECALL.

Key Points:

Voluntary Manufacturer Recall:
  • The recall has been voluntarily initiated by Stryker due to a potential malfunction related to a circuit board component. This issue may impair the device's ability to function or cause failure during critical moments.
Limited Impact:
  • Not all HeartSine samaritan PAD units are affected. Clients are encouraged to verify the status of their units by checking the serial numbers against the list provided by Stryker.
Continued Use:
  • Stryker recommends keeping the affected HeartSine samaritan PAD in service if no alternative defibrillator is available. Internal testing indicates a low probability of failure due to this issue.
No Alternative Brands:
  • At this time, MedAire does not recommend or have access to alternative AED brands. We are closely monitoring the situation and will provide updates as they become available.

Recommendations:

  • Check Your Unit:
  • We strongly recommend that clients check if their AED is affected by the recall. Please visit the Stryker website to verify your unit's serial number: Stryker Product Notices.
  • Submit Your Response:
  • Clients should submit their response electronically via the provided QR code or link: Response Submission, or via email to RSRecall@stryker.com, including necessary details such as customer ID, name, and the number of impacted devices.
  • Stay Informed:
  • We advise clients to continue monitoring the AED situation via the MedAire website and the manufacturer's website, as they will have the most current information.

Should you have any questions or require further assistance, please do not hesitate to contact your account manager.

Attachment: AED Recall Information Document