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 Recall Z-1671-2021 · Posted None
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Recalling FirmPhilips North America Llc
Recall StatusTerminated
Product CodeDSI
Date Initiated2021-02-02
Date Terminated2022-09-20
Product Quantity3 units
Reason for Recall
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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