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[Recalled] 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 c

recall fda device united-kingdom

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductHeartSine 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 signs: Unconsciousness
Brand / manufacturerHeartsine Technologies, Limited
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0124-2013
Country of noticeUnited Kingdom
Risk levelClass I
Hazard typerecall
Notice date13 September 2012
EAN / barcode0400000501

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occures, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emit

This Class I recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Heartsine Technologies, Limited

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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