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Class 2 Device Recall HeartSine |
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| Date Initiated by Firm |
April 08, 2024 |
| Date Posted |
May 14, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1820-2024 |
| Recall Event ID |
94076 |
| Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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| Product |
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
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| 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
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Recalling Firm/
Manufacturer |
HeartSine Technologies Ltd
207 Airport Road West
Belfast United Kingdom
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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.
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FDA Determined
Cause 2 |
Process control |
| Action |
On 04/08/24 Stryker sent correction notices to customers informing them of the following:
1) If affected devices are found, follow the instructions to power cycle your device:
a) Check the expiration date on the rear of 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" to indicate that the tabs on the right and left sides of the Pad-Pak are fully engaged.
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 the On/Off button to turn on.
c) Listen for, but do not follow, the voice prompts to ensure you can hear the 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 the On/Off button to turn off. 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 of this communication.
f) Although this audio issue will not cause a warning message, if any other warning messages are played, or you see a red flashing status indicator, please refer to User Manual (General Troubleshooting).
2) Complete and return the response form to RSRecall@stryker.com.
3) If further distributed, please send an email to RSRecall@stryker.com. Stryker will work with you to ensure recipients are notified.
4) If you have any questions or concerns, please contact HeartSine Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at RSRecall@stryker.com. |
| Quantity in Commerce |
183,248 |
| Distribution |
US 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.
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| Total Product Life Cycle |
TPLC Device Report
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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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