Philips North America: Philips PIC iX Essentials REF:867093

Recall number

Z-3142-2026

Recalling firm

Philips North America

Product

Philips PIC iX Essentials REF:867093

Status

Open, Classified

Initiated

2026-07-31

Posted

2026-09-11

Terminated

not on file

Reason

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

Root cause

Software design

Action

On July 31, 2026, Philips North America LLC issued an urgent medical device correction to affected consignees via USPS certified mail. Philips requested consignees to take the following actions: Users: 1. In cases where central monitoring has halted, please ensure that triaging of patients at bedside and a change in workflow occurs to more closely monitor patient status. Ensure audible alarm volume is on high in-patient rooms in case bedside devices disconnect and do not provide visual indicators that communication with the central. 2. Pass this notice to those who need to be aware within your organization or to any organization where affected product(s) have been potentially transferred. 3. Place this Urgent notification with the documentation of the Philips Patient Information Center (PIC) iX and associate devices in a place where it is most likely to be seen and viewed. 4. Implement the Technical Solution established by Philips as soon as available within the defined timeframe. Distributors: 1. Send the attached URGENT Medical Device Correction to each customer to whom you have distributed any affected product(s) 2. Perform a good faith effort to reach each customer a minimum of three (3) times, and if possible, using multiple contact methods. 3. Implement the Technical Solution established by Philips as soon as available within the timeframe communicated by Philips, and confirm with Philips the implementation of the correction of all affected product(s). In case any product(s) cannot be corrected, inform Philips of the reason why the Technical Solution could not be implemented.

Quantity

312 units

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.

Lot, serial or model codes

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

510(k) numbers

["K153702"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3006648320

Firm city

Cambridge

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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