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Philips Medical Systems, Inc. recalls IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865
Recalled June 18, 2014 · FDA recall Z-1746-2014 · Philips Medical Systems
Hazard
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. · FDA Class II
Units
42,600
Sold at
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
Description
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.
Product
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →