Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-au

FDA device recall Z-1217-2023 · posted 2023-03-03 · Open, Classified

Recall details

Recalling firm

HeartSine Technologies Ltd

Reason for recall

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

Action taken

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, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at heartsinesupport@stryker.com. Language Check: 1) Place device face up on a flat surface and slide the PAD-Pak into the device until you hear a "double click". 2) Verify the green status indicator is blinking. 3) Press the On/Off button. Liston for, but do not follow the voice prompts to ensure no warning messages are played and that the device prompts are in the expected language. 4) Press On/Off button to turn off the device.

Root cause

Process control

Status

Open, Classified

Product code

MKJ

Quantity affected

13

Distribution

US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand

Date initiated

2023-02-01

Date posted

2023-03-03

Location

Belfast, United Kingdom