CLASS II Device recall · Reported 19 Aug 2020 · FDA Enforcement Report
Philips HeartStart MRx, Monitor/Defibrillators recalled
Philips North America is recalling Philips HeartStart MRx, Monitor/Defibrillators. The recall was initiated on 16 Jul 2020 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-2794-2020
- FDA event ID
- 85743
- Recalling firm
- Philips North America, Andover, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2020
- FDA classified
- 13 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 16 Jul 2020 | Recall initiated by company | |
| 13 Aug 2020 | Classified by FDA | +28 days |
| 19 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
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 with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support or defibrillation.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
The therapy switch may fail, resulting in the device exhibiting the following behaviors: the device may not perform the selected function, the therapy knob may not change to the energy setting selected, or the device may deliver a shock with an energy level different from the setting selected by the user. These device behaviors could result in a delay in therapy or a failure to deliver the intended therapy.
Which lots are affected?
All devices are affected
Where was it sold?
Worldwide distribution.
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 North America
All 531| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Brilliance recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips IQon Spectral CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Ingenuity CT recalled by Philips North America | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Philips Brilliance CT 64: Brilliance CT 64 Channel recalled | Philips North America | Device Malfunction | MA |
| Device | CLASS II | Cardiac Workstation recalled by Philips North America | Philips North America | Labeling Errors | Nationwide |
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 |