FDA Devices recall · Reported August 14, 2024
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.
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilitie…
Philips North America Llc recalled IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Mo… - a moderate-severity action.
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Mo… was recalled by Philips North America Llc in August 14, 2024. Reason: Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. C…. Check the official notice for the remedy. Verify recall #Z-2510-2024 with the FDA Devices before acting.
The recall
Philips North America Llc issued this moderate-severity FDA Devices recall-Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. C….
- Moderate
- severity level
- 18 units
- affected scope
- Class II
- classification
- August 14, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2510-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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,
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2510-2024 |
| Date reported | August 14, 2024 |
| Date initiated | June 28, 2024 |
| Recalling firm | Philips North America Llc |
| Firm location | Cambridge, MA |
| Affected scope | 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 Spain Sri Lanka Sweden Switzerland Tai… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2510-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026