High FDA (Devices)·Z-1141-2024·Announced 2024-02-21

HeartSine Samaritan PAD Defibrillators Recalled for Test Configuration Flaw

HeartSine samaritan PAD defibrillators shipped in test configuration may have incorrect CPR timing and delayed or no therapy delivery in cardiac events. Users should stop using affected units and contact the manufacturer.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a life-critical medical device with potential for serious harm, including failure to deliver or delayed delivery of defibrillation therapy during cardiac emergencies. However, no reported illnesses or injuries are documented in the source, making this a theoretical risk-of-harm scenario. Per the rubric, risk-of-harm products without reported injury warrant a score of 3 (High).

Plain-English summary

HeartSine samaritan PAD (Public Access Defibrillator) models, including SAM 350P, SAM 360P, SAM 450P, and SAM 500P, have been recalled by the FDA due to a test configuration issue. The affected defibrillators were shipped in an improper test configuration rather than a production-ready state.

Devices affected by this configuration may display incorrect language, provide incorrect CPR duration instructions (prompting only 5-second intervals), and analyze heart rhythm at inappropriate intervals. This could result in delayed delivery or complete failure to deliver defibrillation therapy during cardiac emergencies, creating a serious risk to patient safety.

The recall affects 12 units with distribution across the United States (Texas, California, Illinois, Colorado, Florida, North Carolina, and Michigan) and internationally (Netherlands, Japan, and New Zealand).

Users and healthcare facilities should immediately discontinue use of any affected defibrillators and contact HeartSine Technologies Ltd for instructions on returning the devices or obtaining service replacements.

The recalled product

Product: HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10
Manufacturer: HeartSine Technologies Ltd
Category: Medical Device — Defibrillator
Hazard: device-malfunction
cpr-timing-error
delayed-therapy
Affected units: 12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

Type/UDI-DI or GTIN/Serial Number: SAM 350P/05060167120671
05060167127670
+M727SAM350P0/$$+7/17D00023014
18D00020508
19D00017655
20D00006524
21D91081653
22D91152391
SAM 360P/05060167127687
05060167127311
5060167122927/21E91049810
23E90001379
23E90010409
SAM 450P/05060167129773
+M727SAM450P0/$$+7
+M727SAM450P0/$$+7/17G00001893
18G00001553
SAM 500P/05060167122453/22B91071233

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · HeartSine Technologies Ltd

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Same hazard · device malfunction