Recall Z-2509-2024 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.
| Date | Aug 5, 2024 (initiated Jun 28, 2024) |
| Status | Open, Classified |
| Reason | Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the |
| Root cause | Software design |
| Action | Philips North America issued URGENT Medical Device Correction on 6/25/24 to End-Users. Philips Market Organizations will distribute the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Use only default measurement capabilities, as indicated in Table 1 above, for monitoring purposes. Pass this notice to all those who need to be aware within your organization or to any organization where affected devices have been potentially transferred. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will relo |
| Quantity | 49 units |
| Distribution | Nationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China Colombia Denmark France Germany Hong Kong India Indonesia Italy Japan Netherlands Portugal Singapore South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand United Kingdom Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130849 | INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Jun 14, 2013 |