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U.S. Department of Health and Human Services

Class 2 Device Recall HeartSine

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  Class 2 Device Recall HeartSine see related information
Date Initiated by Firm February 01, 2023
Date Posted March 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-1217-2023
Recall Event ID 91659
PMA Number P160008 
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator,
SAM 360P fully automatic defibrillator,
SAM 500P semi-automatic defibrillator with CPR Advisor
Code Information 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
Recalling Firm/
Manufacturer		 HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom
For Additional Information Contact
+44 2890939400
Manufacturer Reason
for Recall		 Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
FDA Determined
Cause 2		 Process control
Action On 2/1/23, correction notices were mailed to customers who were asked to do the following: 1) Confirm that the device has incorrect language voice prompts by using the Device Language Check. 2) If the device is found to have incorrect language configuration, remove it form use. The recalling firm will provide a replacement device. 3) Inform the recalling firm of any of the subject devices have been distributed to other organizations. 4) Complete and return the acknowledgement form to heartsinesupport@stryker.com If you have questions or concerns contact Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at heartsinesupport@stryker.com. Language Check: 1) Place device face up on a flat surface and slide the PAD-Pak into the device until you hear a "double click". 2) Verify the green status indicator is blinking. 3) Press the On/Off button. Liston for, but do not follow the voice prompts to ensure no warning messages are played and that the device prompts are in the expected language. 4) Press On/Off button to turn off the device.
Quantity in Commerce 13
Distribution US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MKJ and Original Applicant = HeartSine Technologies, Ltd.
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