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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 14, 2024
Date Posted February 15, 2024
Recall Status1 Open3, Classified
Recall Number Z-1141-2024
Recall Event ID 93962
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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
Code Information 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
Recalling Firm/
Manufacturer		 HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom
For Additional Information Contact Alina Koerts
+31438080
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action On 2/14/24, correction notices were mailed to customers who were asked to do the following: 1) Maintain awareness of this communication internally until the required action has been completed within your facility. 2) Inform the recalling firm if any of the subject devices were distributed to other organizations. The firm will work with you to ensure recipients are notified appropriately. 3) Complete and return the acknowledgment form to RSRecall@Stryker.com Upon receipt of the acknowledgment form, the firm will provide instructions on next steps including device replacement. If you have any questions or concerns, please contact the firm's 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.
Quantity in Commerce 12
Distribution Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, 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.
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