—#187136

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.

FDA product code: DSI — Detector And Alarm, Arrhythmia
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113125
Affected lot / code info: Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

Philips Healthcare conducted site visits on 2/02/21 by Field Service Engineer and provided the customer with RMA to return affected devices. Devices retuned affected device on RMA. Device Replacement provided.

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.

Timeline

Recall initiated: 2021-02-02
Terminated: 2022-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187136. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.