Z-1671-2021Class II

IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 -

Name: Z-1671-2021 IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 -
Creator: Philips North America Llc
Published: 2021-02-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2021-02-02 / Terminated / root cause: manufacturing process

FDA source

Philips North America Llc began a recall of IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording... on 2021-02-02. FDA classified it as Class II and gives the reason as "Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1671-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-02
Posted: 2021-05-21
Terminated: 2022-09-20
Recalling firm: Philips North America LLC
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.
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 3 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Product codes and lots: Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21

Product code DSI

K113125Class IIIntellivue Mx40 Patient MonitorPhilips Medical Systems / cleared 2011-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)