Public recall detail

Heartsine Samaritan PAD 360P, 500P, and 350P

2024-04-04

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Recall Safety notice
Quick summary

Quick summary: Heartsine Samaritan PAD 360P, 500P, and 350P. Date: 2024-04-04.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Heartsine Samaritan PAD 360P, 500P, and 350P. Date: 2024-04-04.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandHeartsine Technologies, Ltd.
ProductHeartsine Samaritan PAD 360P, 500P, and 350P
IssueMedical devices - Performance
Recall classType I
IdentificationRA-75337

Affected products

ProductHeartsine Samaritan PAD 360P
LotMore than 10 numbers, contact manufacturer.
ModelSAM 360P
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHeartsine Samaritan PAD 360P
ProductHeartsine Samaritan PAD 500P
LotMore than 10 numbers, contact manufacturer.
ModelSAM 500P
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHeartsine Samaritan PAD 500P
ProductHeartsine Samaritan PAD 350P
LotMore than 10 numbers, contact manufacturer.
ModelSAM 350P
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionHeartsine Samaritan PAD 350P

Issue

Stryker has determined that a manufacturing related issue may impair device audio prompts. Stryker is issuing a customer notification to remind customers to follow the user manual and power the device upon receipt to ensure the audio prompts function as intended. Recall Start Dates: March 21, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public
CategoryHealth products - Medical devices - Cardiovascular
CompaniesHeartsine Technologies, Ltd. 207 Airport Road West, Belfast, Northern Ireland, Great Britain, BT3 9ED
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-75337
Background{}
CompaniesHeartsine Technologies, Ltd. 207 Airport Road West, Belfast, Northern Ireland, Great Britain, BT3 9ED
AudiencesGeneral public
Source updated2025-01-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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