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Philips North America: Philips Patient Information Center iX REF:866389

Medical DevicesSource: FDA (device) · Date: 2026-09-23

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips North America
Product
Philips Patient Information Center iX REF:866389
Reason / hazard
Due to software malfunction, patient information system may freeze and become unresponsive.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-07-31
Code info
All PIC iX software versions 4.0-4.5/UDI: (01)00884838127067
Product quantity
7359 Units
Voluntary mandated
Voluntary: Firm initiated
City
Cambridge
State
MA
Country
United States
Event id
99566
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