Device recall

Philips PIC iX Essentials REF:867093

FDA recall source

Recall number

Z-3142-2026

Event id

99566

Status

Ongoing

FDA classification

Class II

Recalling firm

Philips North America

Report date

Sep 23, 2026

Posted

Sep 11, 2026

Initiated

Jul 31, 2026

Center classification date

Sep 11, 2026

Product code

MHX

Device type

Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Reason

Due to software malfunction, patient information system may freeze and become unresponsive.

Root cause

Software design

Quantity

312 units

Code info

All PIC iX software versions 4.0-4.5/UDI: (01)00884838122772

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, 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.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K153702

Location

Cambridge, MA, United States