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Recall Observatory FDA recall evidence

Device product

IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352

Z-1746-2014

May 22, 2014

Class II

Product summary

Firm
Philips Medical Systems, Inc.
Event
Event 68349
Status
Terminated
Classification
Class II
Quantity
42,600
Official record key
device-enforcement:Z-1746-2014

Official wording

Reason: IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.

Code information: Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431

Distribution pattern: United States: Nationwide Foreign Countries: Germany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, Turkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, Hong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software revisions B.00 or B.01 may