Avalon Fetal Monitors

Recalling firm
Philips New Zealand Commercial Limited
Product
Avalon Fetal Monitors. [Device]. Model: Philips Avalon FM20 Fetal Monitor M2702A, Avalon FM30 Fetal Monitor M2703A
Reason
The manufacturer has identified that the Avalon Speaker Assembly cable contacts were inserted, rotated 180° relative to the orientation specified. The reversed contacts in the Connector-Housing cause the locking nose to fail to engage the Connector Socket, which permits the cables to be pulled out of the housing and increases the risk of intermittent or permanent loss of speaker output. If users do not routinely have fetal heart rate tones enabled, it may take longer for a speaker malfunction to be identified prior to the occurrence of harm. If audible fetal heart rate tones are enabled,...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-06-18
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/de1ce2c1-7755-4aeb-84eb-0e6c366075b6