IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated fo
FDA device recall Z-2510-2024 · posted 2024-08-05 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- 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,
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 18 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
- Date initiated
- 2024-06-28
- Date posted
- 2024-08-05
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 (K130849) | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2013-06-14 |