Recall Z-3141-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America
Philips Patient Information Center iX REF:866389
| Date | Sep 11, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| 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 you |
| Quantity | 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 cou |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153702 | M3290B Philips IntelliVue Information Center iX Philips Medical Systems, Jun 13, 2016 |