DeviceSignal · Recall classified
HeartSine Technologies Ltd
FDA classified a device recall on 2026-09-04 · Class II · Z-3120-2026
EventRecall classified
Effective2026-09-04
ClassificationClass II
On 2026-09-04 the FDA classified a device recall from HeartSine Technologies Ltd as Class II. Product: HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…. Recall Z-3120-2026. The firm initiated it on 2026-07-27. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-3120-2026
- Classification
- Class II
- Classified on
- 2026-09-04
- Initiated on
- 2026-07-27
- Firm
- HeartSine Technologies Ltd
- Reason
- Due to a damaged (over stretched) membrane tail that causes an intermittent fault.
- 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).
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-3120-2026- Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-23T12:43:31.676Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
fe3671bbc738dbef8540cf33c30dba2fbe5e90573bc07e8de9ed5850d1a34b99- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)