Device recall enforcement reports

Philips PIC iX Essentials REF:867093

Philips North America · Due to software malfunction, patient information system may freeze and become unresponsive.

Class IIOngoingZ-3142-2026
Status
Ongoing
City
Cambridge
State
MA
Country
United States
Classification
Class II
Product type
Devices
Event ID
99566
Recalling firm
Philips North America
Address 1
222 Jacobs St
Address 2
N/A
Postal code
02141-2296
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Recall number
Z-3142-2026
Product description
Philips PIC iX Essentials REF:867093
Product quantity
312 units
Reason for recall
Due to software malfunction, patient information system may freeze and become unresponsive.
Recall initiation date
20260731
Center classification date
20260911
Report date
20260923
Code info
All PIC iX software versions 4.0-4.5/UDI: (01)00884838122772
Distribution pattern

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.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.