Efficia Dfm100, Heartstart Intrepid

Recall Summary Philips is recalling Efficia DFM100 Defibrillator/Monitor devices with software version 2.00.33 because they may fail to start up properly and become unusable during critical moments. The affected devices will repeatedly show a splash screen instead of fully booting, indicated by a red X in the Ready For Use indicator. This recall affects devices distributed to hospitals, pharmacies, and laboratories in New Zealand.

Recalling firm

Philips New Zealand Commercial Limited

Product

Efficia DFM100, HeartStart Intrepid. [Device]. Model: Efficia DFM100 devices with software revision 2.00.33 installed. Affected: Boot-Up Failure with SW 2.00.33

Reason

The manufacturer has identified a potential safety issue with the Efficia DFM100 Defibrillator/Monitor running software version 2.00.33. Affected devices may fail to complete their boot-up sequence. This can occur either:, during manual boot-up when the knob is turned to AED, Manual, or Pacer mode, or, during a self-test when the device is powered off and connected to any power source., Instead of fully booting, the device may repeatedly display the splash screen and will not become available for clinical use. This condition is indicated to the user by a solid red X shown in the Ready For...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-03-10

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/d8a246a7-bf56-45fc-a086-e2bbf0bb5e7a