Philips Medical Systems, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0204-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A

Product Classification:

Class II

Date Initiated: November 19, 2014

Date Posted: November 11, 2015

Recall Number: Z-0204-2016

Event ID: 69712

Reason for Recall:

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

Status: Terminated

Product Quantity: 1553 units

Code Information:

Serial Numbers: US00101159 US00322848 US00326834 US00328432 US00328439 US00328442 US00328443 US00328446 US00328450 US00328461 US00328464 US00328465 US00328468 US00328473 US00328478 US00330393 US00533518 US00533521 through US00535118 US00539526 US00540124 US00543102 US00543104 US00543138 US00543158 US00543161 US00543166 US00543167 US00543187 US00543204 US00543223 US00543239 US00546804

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated