CanadaHeartSine Samaritan PAD defibrillators, models 350P, 360P and 500P (catalogue numbers include 350-TSO-CN-10, 350-BAS-CN-10, 350-BAS-CF-10, 350-STR-CN-10, 360-BAS-CN-10, 360-BAS-CF-10, 360-STR-CN-10, 360-TSO-CN-10, 500-STR-CN-10 and 500-BAS-CN-10) are affected. An internal component called the membrane tail may cause an intermittent fault that can occur while the device is charging, during shock delivery, or after shock delivery, rendering the device inoperable. Contact the manufacturer for additional information.
What's being recalled
Companies: Heartsine Technologies, Ltd., 207 Airport Road West, Belfast, Northern Ireland, United Kingdom, BT3 9ED.
How to identify it
Affected products: HeartSine samaritan PAD 500P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 500-STR-CN-10
Affected products: HeartSine samaritan PAD 500P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 500-BAS-CN-10
Affected products: HeartSine samaritan PAD 360P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 360-BAS-CN-10
Affected products: HeartSine samaritan PAD 360P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 360-BAS-CF-10
Affected products: HeartSine samaritan PAD 360P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 360-STR-CN-10
Affected products: HeartSine samaritan PAD 360P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 360-TSO-CN-10
Affected products: HeartSine samaritan PAD 350P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 350-TSO-CN-10
Affected products: HeartSine samaritan PAD 350P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 350-BAS-CN-10
Affected products: HeartSine samaritan PAD 350P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 350-BAS-CF-10
Affected products: HeartSine samaritan PAD 350P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 350-STR-CN-10
The hazard
Stryker has recently identified an issue with the membrane tail, an internal component, which could cause 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. The device becomes inoperable after the failure occurs.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)