Z-3141-2026Class II

Philips Patient Information Center iX REF:866389

Name: Z-3141-2026 Philips Patient Information Center iX REF:866389
Creator: Philips North America
Published: 2026-07-31
License: https://open.fda.gov/license/

Philips North America / initiated 2026-07-31 / Open, Classified

FDA source

Recall record

Recall number: Z-3141-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-31
Posted: 2026-09-11
Recalling firm: Philips North America
Product: Philips Patient Information Center iX REF:866389
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Due to software malfunction, patient information system may freeze and become unresponsive.
FDA 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 in commerce: 7359 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.
Product codes and lots: All PIC iX software versions 4.0-4.5/UDI: (01)00884838127067

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3141-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3141-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-3142-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11

Product code MHX

K153702Class IIM3290B Philips IntelliVue Information Center iXPhilips Medical Systems / cleared 2016-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)