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HeartSine samaritan PAD (Public Access Defibrillator)… recallZ-1820-2024 · HeartSine Technologies Ltd · initiated Apr 8, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from HeartSine Technologies Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Process control

What the company is doing

On 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: [email protected] -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 [email protected]. 3) If further distributed, email to [email protected]. 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 [email protected]. 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 [email protected] for further alternative solutions that may be applied.

Recall details

Recall number
Z-1820-2024
Status
Open, Classified
Initiated by the company
Apr 8, 2024
Posted by the FDA
May 14, 2024
Recalling firm
HeartSine Technologies Ltd
Quantity
183,248
Product code
MKJ
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.

Product description

HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Devices named in this recall

12 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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