FDAFDA · Food and drugs·Recall number Z-1141-2024
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
Published February 21, 2024 · Recall initiated: February 14, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HeartSine Technologies Ltd
- Distributor
- Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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