← FDA ENFORCEMENT
Z-3141-2026Class II
Philips North America
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Philips North America
Product type
Device
Status
Ongoing
Report date
2026-09-23
Distribution
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, Pa
Firm state
MA
Product quantity
7359 Units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data IntegrityReason for recall
Due to software malfunction, patient information system may freeze and become unresponsive.
Product description
Philips Patient Information Center iX REF:866389
Code / lot info
All PIC iX software versions 4.0-4.5/UDI: (01)00884838127067
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →