Recall Z-1820-2024 ยท MKJ Automated External Defibrillators (Non-Wearable)
HeartSine Technologies Ltd
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
| Date | May 14, 2024 (initiated Apr 8, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 p |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.