Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 35446 |
| Brand Name: | HeartSine Technologies - Defibrillator, semi-automated |
| Model: | SAM 350P and SAM 500P |
| Affected: | 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. |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | HeartSine Technologies Ltd |
| Brand Name: | HeartSine Technologies - Non-rechargeable public automated external defibrillator |
| Model: | SAM 360P |
| Affected: | 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. |
| Software version: | |
| Recalling Organisation: | Stryker New Zealand Ltd 515 Mount Wellington Highway Mount Wellington AUCKLAND 1060 |
| Contact Information: | 0800 787 9287 |
| Manufacturer: | HeartSine Technologies Ltd |
| Issue: | 23/7/26: Update - The manufaturer has identified a problem with the membrane tail, an internal component, which may result in an intermittent fault. This failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery. If this failure occurs, the device becomes inoperable. The manufacturer has identified that a limited number of HeartSine® Samaritan® PAD devices were distributed without the required maintenance supplement. This supplement contains periodic maintenance instructions implemented as an additional risk-control measure. It was determined during internal quality testing that a manufacturing process 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 in preparation to deliver therapy, while delivering a shock, or after shock delivery. |
| Recall action type: | Recall |
| Recall action: | Product to be exchanged |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 23/7/2026 |
