FDA-Device2015-11-11Class II
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Philips Medical Systems, Inc.
Hazard
1. Device will perform the weekly automated tests hourly, which could cause the therapy capacitors to degrade sooner than intended and 2. While connected to AC or DC power and with no battery installed or the battery installed has a charge level of less than 10%, the Ready for Use (RFU) indicator will not provide the expected low battery indication
Sold states
Worldwide Distribution - USA (nationwide), Australia, Austria, Bahrain, Belgium, Brunei Darussalam, Canada, China, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Republic of Korea, Libyan Arab Jamahiriya, Lithuania, Mexico, Namibia, Netherlands, Palestine, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates and United Kingdom.
Affected count
1553 units
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0204-2016Don't want to check this manually?
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