FDA Device recall Z-1671-2021

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monit…

• FDA Device
• Class II
• terminated
• Published 2021-06-02

On 2021-06-02 the FDA classified a Class II recall of IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monit… by Philips North America, citing manufacturing failed to follow process steps resulting in the distribution of potentially defective devices.

Read the official FDA Device notice

Product

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Reason

Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.