Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36459 |
| Brand Name: | Philips HEARTSTREAM Efficia DFM100 Defibrillator/Monitor |
| Model: | HEARTSTREAM Efficia DFM100 Defibrillator/Monitor |
| Affected: | Efficia DFM100 devices with software revision 2.00.33 installed |
| Software version: | |
| Recalling Organisation: | Clinical & Regulatory Services Limited 30 Fulford Road Havelock North Hastings 4130 |
| Contact Information: | (06) 844 4490 |
| Manufacturer: | Philips Goldway (Shenzhen) Industrial Inc |
| Issue: | The Efficia DFM100 Defibrillator/Monitor, with software revision 2.00.33 installed, may fail to complete its boot-up sequence. This could occur either 1) during manual boot-up if the knob is turned to AED/Manual/Pacer or 2) as part of a self-test if the device is turned off and connected to any power source. Instead of completing the boot-up sequence, the device may repeatedly display the splash screen and will not be available for clinical use. This will be indicated to the user by displaying a solid red X in the Ready For Use (RFU) indicator. |
| Recall action type: | Correction |
| Recall action: | Software to be upgraded |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/1/2026 |
