Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
This recall has been terminated (originally issued November 3, 2015).
- Company
- Philips Medical Systems, Inc.
- Recall Initiated
- November 19, 2014
- Posted
- November 3, 2015
- Terminated
- August 15, 2016
- Recall Number
- Z-0204-2016
- Quantity
- 1553 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
Distribution
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.
Lot / Code Info
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
Root Cause
Process control
Action Taken
Philips Healthcare sent an " Urgent Field Safety Notice " dated November 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A hardware upgrade will be provided free of charge for all units affected by this issue. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: A Philips authorized service provider will service the device and ensure it is operating within specification. Prior to receiving service, you can continue to use your MRx provided that the following steps are followed. These steps will prevent further accelerated degradation of the therapy capacitor, and will eliminate the above described behavior for no/low battery conditions. To correct the problem, set the configuration of the MRx to factory defaults in configuration mode. Please contact your local Philips Service Representative for further questions, or call (978) 687-1501.