The Recall Desk

Manufacturer

Heartsine Technologies, Limited

2 recalls in our database name Heartsine Technologies, Limited as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2014-07-30

Of the 2 recalls from Heartsine Technologies, Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2115-2014·2014-07-30

    Heartsine AED Electrode Pouches Recalled for Difficulty Opening

    Heartsine is recalling Pad-Pak and Pedi-Pak electrode accessories for the Samaritan PAD 300P and 350P because some sealed foil pouches are difficult to open, potentially delaying therapy.

    Product
    Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P). Automated External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0124-2013·2012-11-07

    HeartSine Samaritan 300/300P PAD Devices Recalled for Malfunction

    Heartsine is recalling 81,982 Samaritan 300/300P PAD devices because they may turn on or off unexpectedly, potentially preventing therapy delivery during cardiac arrest.

    Product
    HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following sign
    Category
    Medical Device
    Distribution
    Distributed nationwide