FDA-Device2022-04-13Class II
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Philips North America LLC
Hazard
There is a potential for AED pads to experience gel separation from the foam/tin backing when peeled from the plastic liner. The gel may fold onto itself resulting in reduced surface area or gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad.
Sold states
Worldwide distribution. US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, Croatia, French Guiana, Denmark, United Arab Emirates, Hungary, Belgium, Indonesia, Korea, Republic of, Bhutan, New Zealand, Bulgaria, Mauritius, Trinidad and Tobago, Israel, Guatemala, Mali, Algeria, Philippines, Malta, Curacao, Panama, Paraguay, Costa Rica, Colombia, Liechtenstein, Saudi Arabia, Monaco, Estonia, Senegal, Reunion, Luxembourg, Qatar, El Salvador, Namibia, Myanmar, Nigeria, Poland, Aruba, Greece, Martinique, Guadeloupe, Dominican Republic, China, Kosovo, Portugal, Bangladesh, Tanzania, Peru, Lithuania, New Caledonia, State of Palestine, Finland, Cambodia, Macao, Cyprus, Zambia, Viet Nam, Uruguay, Ecuador, Netherlands Antilles, Czech Republic, French Polynesia, Kenya, Cameroon, Guinea, Mayotte, and Brunei Darussalam.
Affected count
1,696,047
Manufactured in
22100 Bothell Everett Hwy, Bothell, WA, United States
Products
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0881-2022Don't want to check this manually?
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