CanadaHeartSine Samaritan PAD models SAM 350P, SAM 360P and SAM 500P may be affected; affected 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-TSO-CN-10, 500-STR-CN-10, 500-BAS-CN-10 and 500-BAS-CF-10, and affected lot/serial numbers are indicated as more than 10 numbers (contact the manufacturer to confirm). These devices were distributed without the required maintenance supplement containing periodic maintenance instructions; the issue was identified through a customer complaint. Contact the manufacturer if you require 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 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-TSO-CN-10
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 500P; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 500-BAS-CF-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 identified a limited number of HeartSine samaritan PAD devices that were distributed without the required maintenance supplement. This supplement contains periodic maintenance instructions implemented as an additional risk-control measure. While most devices contain the maintenance supplement, this voluntary correction is being initiated to ensure all end users have access to supplemental maintenance information. This issue was identified through a customer complaint.
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)