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What is the problem?
Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators.
A manufacturing problem related to a circuit board component may impair the device’s ability to function or cause failure. This failure could occur at any point when the device is holding a charge. This may be in preparation to deliver therapy, while delivering a shock, or after shock delivery.
The device becomes inoperable after the failure occurs.
The problem was observed during quality testing and not during patient use.
| ARTG number | Catalogue number | Product model | Affected serial numbers |
|---|---|---|---|
| 156690, 228210 | 350BASUK10 | HeartSine SAM 350P | A subset of serial numbers beginning with 21, 22, 23 or 24, and are then followed by the letter B, D, E, G or H. Please check if your AED serial number is affected as detailed below. To view the list of all serial numbers included in this recall, please visit the Stryker website. |
360BASUK10 360BASUKGW | HeartSine SAM 360P | ||
| 500BASUK10 | HeartSine SAM 500P |
What are the risks?
The problem could lead to:
- No shock delivery
- Delay in treatment
What should I do?
- Contact Styker via email on heartsine.recall@stryker.com or call on 02 9170 9131. You can also notify Stryker via an online form.
- Once your response is received, Stryker will contact you to organise a replacement device.
- In the meantime, Stryker recommends keeping your HeartSine Samaritan PAD in service until a replacement device is available.
Further information
Please contact Stryker on 02 9170 9131 or email heartsine.recall@stryker.com for further information.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.