Devices

Philips Heartstart HS1 OnSite

Model / Serial
SERIAL NUMBERS--MODEL M5066A: A10C-04048, A10C-04050, A10C-04300, A10C-04301, A10C-04302, A10C-04315, A10C-04316, A10C-04317, A10C-04318, A10C-04319, A10C-04320, A10C-04321, A10C-04322, A10C-04324, A10C-04325, A10C-04326, A10C-04327, A10C-04328, A10C-04330, A10C-04332, A10C-04333, A10C-04334, A10C-04335, A10C-04337, A10C-04338, A10C-04339, A10C-04340, A10C-04351, A10C-04352, A10C-04353, A10C-04354, A10C-04356, A10C-04357, A10C-04358, A10C-04359, A10C-04360, A10C-04361, A10C-04363, A10C-04364, A10C-04365, A10C-04366, A10C-04367, A10C-04368, A10C-04369, A10C-04611, A10C-04763, A10C-04812, A10C-04824, A10C-04824, A10C-05077, A10C-05078, A10C-05079, A10C-05080, A10C-05081, A10C-05083, A10C-05086, A10C-05087, A10C-05088, A10C-05089, A10C-05098, A10C-05151, A10C-05185, A10C-05191, A10C-05206, A10C-05207, A10C-05211, A10C-05212, A10C-05215, A10C-05216, A10C-05219, A10C-05233, A10C-05314, A10C-05315, A10C-05324, A10C-05397, A10C-05398, A10C-05429, A10C-05554, A10C-05569, A10C-05570, A10C-05571, A10C-05575, A10C-05578, A10C-05579, A10C-05580, A10C-05581, A10C-05583, A10C-05584, A10C-05585, A10C-05586, A10C-05587, A10C-05588, A10C-05591, A10C-05592, A10C-05593, A10C-05594, A10C-05595, A10C-05597, A10C-05599, A10C-05600, A10C-05751, A10C-05752, A10C-05759, A10C-05763, A10C-05764, A10C-05765, A10C-05767, A10C-05768, A10C-05769, A10C-05770, A10C-05771, A10C-05772, A10C-05775, A10C-05776, A10C-05777, A10C-05778, A10C-05779, A10C-05780, A10C-05781, A10C-05784, A10C-05785, A10C-05786, A10C-05787, A10C-05788, A10C-05789, A10C-05791, A10C-05792, A10C-05800, A10C-05913, A10C-05941, A10C-05968, A10C-05969, A10C-05970, A10C-05976, A10C-05977, A10C-05982, A10C-05983, A10C-06001, A10C-06002, A10C-06003, A10C-06006, A10C-06011, A10C-06013, A10C-06018, A10C-06020, A10C-06026, A10C-06027, A10C-06028, A10C-06354, A10C-06355, A10C-06356, A10C-06357, A10C-06358, A10C-06359, A10C-06360, A10C-06361, A10C-06364, A10C-06365, A10C-06366, A10C-06367, A10C-06368, A10C-06369, A10C-06370, A10C-06371, A10C-06372, A10C-06373, A10C-06374, A10C-06375, A10C-06376, A10C-06377, A10C-06378, A10C-06379, A10C-06381, A10C-06382, A10C-06383, A10C-06384, A10C-06385, A10C-06386, A10C-06387, A10C-06388, A10C-06390, A10C-06391, A10C-06392, A10C-06393, A10C-06394, A10C-06395, A10C-06396, A10C-06399, A10C-06400, A10C-06401, A10C-06402, A10C-06403, A10C-06404, A10C-06405, A10C-06406, A10C-06407, A10C-06408, A10C-06410, A10C-06411, A10C-06417, A10C-06418, A10C-06419, A10C-06420, A10C-06421, and A10C-06423.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution -- USA, Canada, Japan, United Arab Emirates, Austria, Switzerland, Germany, Spain, France, Italy, and Norway.
Product Description
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model number M5066A). || Device is designed for use on a person in sudden cardiac arrest who is unresponsive when shaken and not breathing normally
Manufacturer
Philips Medical Systems
1 Event
- Recall of Philips Heartstart HS1 OnSite

Manufacturer

Philips Medical Systems

Manufacturer Address
Philips Medical Systems, 2301 5th Ave Ste 200, Seattle WA 98121
Source
USFDA

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