Patient Information Center iX recallZ-3141-2026 · Philips North America · initiated Jul 31, 2026

Why it was recalled

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number

Z-3141-2026

Status

Open, Classified

Initiated by the company

Jul 31, 2026

Posted by the FDA

Sep 11, 2026

Recalling firm

Philips North America

Quantity

7359 Units

Product code

MHX

FDA submissions

K153702

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.

Product description

Philips Patient Information Center iX REF:866389

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Patient Information Center iX 4.4

  Philips Medizin Systeme Böblingen GmbH · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
  1 recall7 deaths84 reports

Product lines

• Patient Information Center iXPhilips Medizin Systeme Böblingen GmbH · 9 models · 406 reports · 7 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 99566).

• Z-3142-2026 · Open, Classified
  Philips PIC iX Essentials REF:867093