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.

Recall Insight

This FDA Devices action (record #Z-1671-2021) was formally reported on June 2, 2021, with the manufacturer initiating the action on February 2, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips North America Llc is listed as the recalling firm, operating out of Cambridge, MA. Federal records indicate 3 units units are affected.

The documented reason for this recall is: Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.