FDA-Device2026-09-23Class IIPROCESSING DEFECT
Philips PIC iX Essentials patient information system recalled for software freeze risk
What this means
A software malfunction in certain versions of the Philips PIC iX Essentials patient information system can cause the system to freeze and become unresponsive. The affected software versions are 4.0 through 4.5. No injuries have been reported.
- Check if your system is running software version 4.0–4.5
- Contact Philips North America for a software update or corrective action
- Do not rely on a frozen system for patient care decisions
The agency's original wording
Hazard
Due to software malfunction, patient information system may freeze and become unresponsive.
Intended for
Adults
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
312 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips PIC iX Essentials REF:867093
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3142-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.