HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P - Membrane Tail
Brand(s)
Last updated
Summary
Product
HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P - Membrane Tail
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Industry
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| HeartSine samaritan PAD 500P | More than 10 numbers, contact manufacturer. | 500-STR-CN-10 |
| HeartSine samaritan PAD 500P | More than 10 numbers, contact manufacturer. | 500-BAS-CN-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CN-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-BAS-CF-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-STR-CN-10 |
| HeartSine samaritan PAD 360P | More than 10 numbers, contact manufacturer. | 360-TSO-CN-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-TSO-CN-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-BAS-CN-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-BAS-CF-10 |
| HeartSine samaritan PAD 350P | More than 10 numbers, contact manufacturer. | 350-STR-CN-10 |
Issue
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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
Heartsine Technologies, Ltd.
207 Airport Road West, Belfast, Northern Ireland, United Kingdom, BT3 9ED
Published by
Health Canada
Audience
Industry
Recall class
Type II
Recall date
Identification number
RA-82380
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