CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
Philips HeartStart MRx Monitor/Defibrillators recalled
Philips Medical Systems is recalling Philips HeartStart MRx Monitor/Defibrillators, distributed nationwide in the US. The recall was initiated on 19 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0204-2016
- FDA event ID
- 69712
- Recalling firm
- Philips Medical Systems, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2014
- FDA classified
- 3 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 19 Nov 2014 | Recall initiated by company | |
| 3 Nov 2015 | Classified by FDA | +349 days |
| 11 Nov 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Philips Medical Systems
All 81| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | IQon Spectral CT IQon Spectral CT Upgrades recalled | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Spectral CT on Rails recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Model: Incisive CT; Product Code (REF): (1) 728143, (2) recalled | Philips Medical Systems | Device Malfunction | 18 states |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |