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Philips Medical Systems, Inc. recalls Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Recalled November 11, 2015 · FDA recall Z-0204-2016 · Philips Medical Systems
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 · FDA Class II
Units
1553 units
Sold at
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.
Description
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
Product
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →