Recall Z-3120-2026 ยท MKJ Automated External Defibrillators (Non-Wearable)
HeartSine Technologies Ltd
HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min C
| Date | Sep 4, 2026 (initiated Jul 27, 2026) |
| Status | Open, Classified |
| Reason | Due to a damaged (over stretched) membrane tail that causes an intermittent fault. |
| Root cause | Process control |
| Action | On 07/28/2026, several versions of an "Urgent: Medical device recall" letter that outlines multiple issues: 1) Stryker identified an issue with the membrane tail, an internal component, which could cause an intermittent fault. This failure could occur at any point when the device is holding a charge in preparation to deliver therapy, while delivering a shock, or after shock delivery. The device becomes inoperable after the failure occurs. 2) Stryker has also identified that a limited number of HeartSine samaritan PAD devices were distributed without the required maintenance insert. This ins |
| Quantity | 11,912 |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME MI, MN, NC, NJ, NM, NV, NY, OH, OK, OR, PA, SD,TN, TX, UT, VA, WA, WI, WV and WY. The countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Hong Ko |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.