Recall Z-1827-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
| Date | May 15, 2024 (initiated Apr 19, 2024) |
| Status | Open, Classified |
| Reason | Event Catalog information does not save when copied and transferred from one unit to another. |
| Root cause | Software design |
| Action | Consignees were sent an "URGENT Medical Device Correction," notification, dated 4/12/24. Consignees are instructed in the notification to review in Events Monitor and confirm the expected category is assigned for the reviewed event. If events are not assigned to the correct category consignees are not to depend on event notification for patient monitoring. The provided recall notification should be provided to all users of affected devices and to those the device was further distributed, for their awareness. Philips will contact consignees to schedule a visit from a Philips Field Service Engin |
| Quantity | 358 units (US: 45; OUS: 313) |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, MA, MI, MN, MO, NJ, NM, NY, OH, PA, TN, TX, WA, WV, & DC. The countries of AE, AT, AU, BE, BR, CA, CH, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IN, IT, JP, KR, LT, NL, NO, OM, PL, PT, RO, SE, SG, SK, TH, & ZA. |
| 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 |