HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10

Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.

On 2/14/24, correction notices were mailed to customers who were asked to do the following: 1) Maintain awareness of this communication internally until the required action has been completed within your facility. 2) Inform the recalling firm if any of the subject devices were distributed to other organizations. The firm will work with you to ensure recipients are notified appropriately. 3) Complete and return the acknowledgment form to [email protected] Upon receipt of the acknowledgment form, the firm will provide instructions on next steps including device replacement. If you have any questions or concerns, please contact the firm's Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday - Friday or by email at [email protected].