PLEASE FORWARD TO THE RESPONSIBLE PERSON (DEVICE OFFICER, MEDICAL DEVICE RESPONSIBLE PARTY)!

Dear customer,

This recall notice is being issued to inform customers with HeartSine defibrillators of a potential malfunction of the device. As a precautionary measure, Stryker is conducting a voluntary recall of these devices.

Here you can find the manufacturer's original announcement: Notification of the recall of medical devices

Stryker advises all customers who have received affected HeartSine samaritan PAD devices to follow the steps described above. Once your response has been received and a replacement device is available, Stryker will contact you as soon as possible to arrange the next steps for receiving a replacement.

You can check here whether your device is affected by the measure:
https://www.stryker.com/de/de/emergency-care/product-notices/heartsine/fa318-t3.html

We thank you for your help and support in carrying out this campaign and regret any inconvenience that may arise as a result.

Best regards
on behalf of the manufacturer
your MedX5 team

FAQ about the HeartSine situation

1

Does the recall have anything to do with the loudspeakers and the measure from 2024?

Beyond the information now available, we have no further details. Just like in 2024, we were all presented with a fait accompli.

2

Why are PAD-PAK cassettes no longer manufactured and distributed?

We have no further details from the manufacturer on this matter either. They have indicated that deliveries should resume by mid/late Q3.

3

What should I do when the PAD-PAK cassette has expired?

Since the manufacturer offers no support whatsoever, we can only offer you an exchange of the device for a new defibrillator from another manufacturer.

4

What should I do after using the product?

Here too, we recommend replacing the device. We are working on a temporary solution, but this cannot be implemented with HeartSine devices.

5

Will the situation improve? Will the devices and accessories be available again?

We hope this is the case for all our HeartSine customers. Unfortunately, we have no information regarding the cause or the next possible delivery date.

6

Are spare parts really no longer available anywhere?

Yes, the current global supply situation has been in place since January 2025.

7

Is there an alternative to HeartSine defibrillators?

Of course, we offer an alternative. The devices are already compliant with the 2027 Medical Device Operator Ordinance (MPBetreibV) and are also available with remote monitoring upon request.

8

How can I be sure that I will not be confronted with a similar situation again in the future?

Rent or lease! MedX5 operates the devices and is therefore responsible – this includes the device, accessories, updates, and service. We would be happy to provide you with a quote.