Recall Z-3120-2026
- Recall number
- Z-3120-2026
- Event number
- 99568
- Firm
- HeartSine Technologies Ltd
- Firm FEI
- 3004123209
- Product code
- MKJ
- Status
- Open, Classified
- Initiated
- 2026-07-27
- Posted
- 2026-09-04
- Root cause
- Process control
- 510(k) numbers
- K112432, K002445, K133484, K081371, K092598, K081828, K052161, K003565, K040256, K002232, K970391, K091548, K080421, K042088, K022732, K141774, K042417, K013425, K120907, K003228, K033474, K082090, K062970, K993533, K033771, K060934, K990106, K014157, K981802, K051632
Product#
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 CPR) UDI-DI code: 0506016712069 The HeartSine samaritan PAD (Public Access Defibrillator) Models SAM 350P, SAM 360P and SAM 450P are indicated for use on victims of cardiac arrest who are exhibiting the following signs: " Unconscious " Not breathing " Without circulation (without a pulse) The devices are indicated for use on patients greater than 8 years old or over 55 lbs. (25 kg) when used with the adult Pad-Pak (Pad-Pak-01 or Pad-Pak-07). They are indicated for use on children between 1 and 8 years of age or up to 55 lbs. (25 kg) when used with the Pediatric-Pad (Pad-Pak-02).
Reason for Recall#
Due to a damaged (over stretched) membrane tail that causes an intermittent fault.