Philips IntelliVue Measurement Module X1 Model: M3001A

Recall Insight

This FDA Devices action (record #Z-0853-2016) was formally reported on March 2, 2016, with the manufacturer initiating the action on January 4, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Philips Electronics North America Corporation is listed as the recalling firm, operating out of Andover, MA. Federal records indicate 13,300 units are affected.

The documented reason for this recall is: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor Distribution data in the federal record shows the product reached: Worldwide Distribution - Nationwide Distribution and to the countries of : Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican…. 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 10 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.