Philips Heartstream Efficia Dfm100 Defibrillator/monitor
- Recalling firm
- Clinical & Regulatory Services Limited
- Product
- Philips HEARTSTREAM Efficia DFM100 Defibrillator/Monitor. [Device]. Model: HEARTSTREAM Efficia DFM100 Defibrillator/Monitor. Affected: Efficia DFM100 devices with software revision 2.00.33 installed
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-01-08
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/14bbf0d2-9125-4869-86c3-e3f56ef640bc