Heartsine Technologies - Defibrillator, Semi-automated
- Recalling firm
- Stryker New Zealand Ltd
- Product
- HeartSine Technologies - Defibrillator, semi-automated. [Device]. Model: SAM 350P and SAM 500P; 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.; 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.. Also covers: HeartSine Technologies - Non-rechargeable public automated external defibrillator
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-07-23
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/bc56efa9-adaf-4c7e-8b9e-9b92e63d5196