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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 HeartSinesee related information
Date Initiated by FirmApril 08, 2024
Date PostedMay 14, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1820-2024
Recall Event ID 94076
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
ProductHeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Code Information UDI-DI: 5060167125379, 5060167120688, 5060167125720, 5060167128066, 5060167122330, 5060167122491, M727SAM450P, 5060167122514, 5060167121371, 5060167120671, 5060167121630, 5060167128042, 5060167120701, 5060167128080, 5060167120695, 5060167120725, 5060167120718, 5060167120909, 5060167120916, 5060167122071, 5060167120893. Devices affected by this notification begin with the following prefixes and device codes: 16D, 16E, 16G, 17D, 17E, 17G, 18D, 18E, 18G, 19D, 19E, 19G, 20D, 20E, 20G, 21D, 21E, 21G, 22D, 22E, 22G, 23D, 23E, 23G, 24D, 24E, 24G Serial Numbers: The prefix (device identifier) consists of the manufacturing date (YY) and the device model (B, D, E, G, or H) and an 8-digit serial number string. Example: 16D00001234
FEI Number 3004123209
Recalling Firm/
Manufacturer		 HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom
Manufacturer Reason
for Recall		Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
FDA Determined
Cause 2		Process control
ActionOn 04/08/24 Stryker sent correction notices to customers informing them of the following: 1) Follow instructions to power cycle affected devices: a) Check the expiration date on the Pad-Pak and if passed, do not use and replace the expired Pad-Pak. b) Place the affected device face up on a flat surface and slide the Pad-Pak into the affected device until you hear the "double click." c) Verify that the green Status indicator is blinking to indicate the initial self-test routine has been performed and the device is ready for use. d) Press On/Off button. c) Listen for, but do not follow, voice prompts. -If you do not hear a prompt, contact your Authorized Distributor or HeartSine Technologies Technical Support at: heartsinesupport@stryker.com -If you hear prompt "Adult patient" and/or "Call for medical assistance", no further action is needed. d) Press On/Off button. If you have not heard a warning message and the status indicator continues to flash green, the device is ready for use. e) Carry out check once every three months and maintain awareness. f) Audio issue will not cause a warning message, but if any other warning messages are played, or you see a red flashing status indicator, please refer to User Manual (General Troubleshooting). 2) Complete/return the response form to RSRecall@stryker.com. 3) If further distributed, email to RSRecall@stryker.com. Stryker will work with you to ensure recipients are notified. 4) If you have any questions or concerns, contact Customer Support at +44 28 9093 9400, 9A.M. to 5P.M. (GMT), or by email at RSRecall@stryker.com. On 3/17/2025, additional correction notices were sent and in addition customers were informed: - Keep track of the total number of impacted devices as well as the number of devices that do not provide audio prompts (if any). - If unable to complete this check every 3 months, please reach out to RSRecall@stryker.com for further alternative solutions that may be applied.
Quantity in Commerce183,248
DistributionUS Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
Total Product Life CycleTPLC 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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