Recall Z-1217-2023 ยท MKJ Automated External Defibrillators (Non-Wearable)
HeartSine Technologies Ltd
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
| Date | Mar 3, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. |
| Root cause | Process control |
| Action | On 2/1/23, correction notices were mailed to customers who were asked to do the following: 1) Confirm that the device has incorrect language voice prompts by using the Device Language Check. 2) If the device is found to have incorrect language configuration, remove it form use. The recalling firm will provide a replacement device. 3) Inform the recalling firm of any of the subject devices have been distributed to other organizations. 4) Complete and return the acknowledgement form to heartsinesupport@stryker.com If you have questions or concerns contact Customer Support at +44 28 9093 9400, |
| Quantity | 13 |
| Distribution | US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.