FDA-Device2026-01-28Class II
Patient Information Center iX; Software Version Number: 4.5.0
Philips North America
Hazard
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Canada, Czech Republic, Dominican Rep, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Utd.Arab.Emir.
Affected count
146 units (41 US, 105 OUS)
Manufactured in
222 Jacobs St, Cambridge, MA, United States
Products
Patient Information Center iX; Software Version Number: 4.5.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1156-2026Don't want to check this manually?
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