IntelliVue Patient Monitor MX500 (Philips) – Software Configuration (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. 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.
Brand
Philips North America Llc
Lot Codes / Batch Numbers
UDI: 00884838038776
Products Sold
UDI: 00884838038776
Philips North America Llc is recalling IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: due to Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Recommended Action
Per FDA guidance
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 reload the current device software to enable missing options (MOS, M06, M20). If you need any further information, please contact your local Philips representative or call 1-800-722-9377.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026