Urgent Field Safety Notice For Masimo Spco/spmet Sensors By Medical (physio-control Inc.), Masimo Corporation

Masimo SPCO/SpMet Sensors Recall Summary Masimo SPCO/SpMet sensors manufactured by Physio-Control Inc./Masimo Corporation are subject to an urgent field safety notice due to a potential safety issue. This Class I recall affects devices distributed in Germany and the EU. The specific technical reason for the recall relates to risk assessment findings that prompted corrective actions.

Recalling firm

Urgent Field Safety Notice for Masimo SPCO/SpMet Sensors by Medical (Physio-Control Inc.), Masimo Corporation , Download

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Masimo SPCO/SpMet Sensors by Medical (Physio-Control Inc

Reason

assessment Field corrective actions Urgent Field Safety Notice for Masimo SPCO/SpMet Sensors by Medical (Physio-Control Inc

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-06-17

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/ae2ab17d-a3b7-4dd7-8360-2bea77815cae