FDAFDA · Food and drugs·Recall number Z-1746-2014
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Published June 18, 2014 · Recall initiated: May 22, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- 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
- Lot
- Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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