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HeartSine Samaritan PAD 350P recallZ-1217-2023 · HeartSine Technologies Ltd · initiated Feb 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from HeartSine Technologies Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 [email protected] 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 [email protected]. 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.

Recall details

Recall number
Z-1217-2023
Status
Open, Classified
Initiated by the company
Feb 1, 2023
Posted by the FDA
Mar 3, 2023
Recalling firm
HeartSine Technologies Ltd
Quantity
13
Product code
MKJ
FDA submissions
P160008
Distribution
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand

Product description

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor

Code information (models, lots, serial numbers)

REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

15 devices cleared under P160008 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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