Heartsine Samaritan PAD defibrillators distributed with incorrect language configuration
Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.
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 (AED) with a configuration defect that could prevent emergency therapy delivery. While no illnesses or deaths have been reported, the potential for serious harm in cardiac emergencies justifies a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
HeartSine Technologies has recalled 13 Samaritan PAD automated external defibrillators (models SAM 350P, SAM 360P, and SAM 500P) due to incorrect language configuration in the affected units. The devices were potentially distributed with the wrong language settings, which can prevent users from following proper therapy instructions.
When an AED has the incorrect language configuration, users may experience a delay in therapy or may not receive therapy at all. This is especially critical in cardiac emergency situations where rapid defibrillation is life-saving.
The affected units were distributed in the United States (New Jersey, Pennsylvania, Wisconsin, Nebraska, Texas, California, Arizona, and Arkansas) and internationally (Australia, Czechia, Canada, and New Zealand). Affected unit serial numbers have been identified by HeartSine Technologies for each model variant.
If you have one of these devices, contact HeartSine Technologies to verify whether your unit is affected and to arrange for the appropriate corrective action.
The recalled product
- Product
- Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
- Manufacturer
- HeartSine Technologies Ltd
- Hazard
- language-misconfiguration
- therapy-delay
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 (15)
- REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810
- 19D00027547
- 19D00030364
- 20D00000454
- 20D00000868
- 20D00006232
- 22D91125401
- 16D01000729
- 22D91145062
- SAM 360P/5060167127120
- 5060167128028/20E90006314
- 21E91040881
- SAM 500P/5060167126505
- 5060167125843/17B00003113
- 20B90000080
Distribution
Distributed in 8 states:
- AR
- AZ
- CA
- NE
- NJ
- PA
- TX
- WI
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