Skip to content
Recall Observatory FDA recall evidence

Device product

Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.

Z-0544-2021

November 18, 2020

Class II

Product summary

Firm
Philips North America Llc
Event
Event 86848
Status
Terminated
Classification
Class II
Quantity
16 total: 2 units US ; 14 OUS
Official record key
device-enforcement:Z-0544-2021

Official wording

Reason: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.

Code information: Serial Numbers: US: DE73607502 DE73607498 OUS: System Serial Number DE95038935 DE73608191 DE73608209 DE73601727 DE73604240 DE73601547 DE73601596 DE73604182 DE83617535 DE73608259 DE83617500 DE83617522 DE73601651

Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.