FDA-Device2026-09-23Class IIPROCESSING DEFECT
Philips Patient Information Center iX software malfunction may cause system freeze
What this means
A software malfunction in Philips Patient Information Center iX (versions 4.0–4.5) can cause the patient information system to freeze and stop responding. This affects healthcare facilities using the affected software versions worldwide.
- If you operate this system, contact Philips North America for a software update or guidance.
- Do not rely on the system if it freezes; have a backup patient information process ready.
The agency's original wording
Hazard
Due to software malfunction, patient information system may freeze and become unresponsive.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Andorra, Utd. Arab. Emir., Argentina, Austria, Australia, Aruba, Bosnia-Herz., Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep, Algeria, Estonia, Spain, Finland, Fiji, Faroe Islands, France, United Kingdom, Gibraltar, Guadeloupe, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iceland, Italy, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon , Sri Lanka, Lithuania, Luxembourg, Latvia, Libya, Morocco, Monaco, Montenegro, Macedonia, Macao, Martinique, Maldives, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, Philippines, Pakistan, Poland, Puerto Rico, Portugal, Qatar R¿union, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Turkmenistan, Tunisia, T¿rkiye, Taiwan, Ukraine, Uzbekistan, Vietnam, South Africa.
Affected count
7359 Units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Patient Information Center iX REF:866389
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3141-2026More Philips recalls
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