Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 14, 2024
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.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America Llc recalled IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements M… - a moderate-severity action.
IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements M… 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-2509-2024 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
- 49 units
- affected scope
- Class II
- classification
- August 14, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2509-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2509-2024) was formally reported on August 14, 2024, with the manufacturer initiating the action on June 28, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips North America Llc is listed as the recalling firm, operating out of Cambridge, MA. Federal records list the affected scope as 49 units.
The documented reason for this recall is: 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 proce… Distribution data in the federal record shows the product reached: 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 Sw…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
49 units
Related Recalls
6
3 from same agency
Product description
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.
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-2509-2024 |
| Date reported | August 14, 2024 |
| Date initiated | June 28, 2024 |
| Recalling firm | Philips North America Llc |
| Firm location | Cambridge, MA |
| Affected scope | 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 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-2509-2024) 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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Philips North America Llc. Units affected: 49 units.
Why was this product recalled? ▼
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,
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2509-2024.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2509-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 14, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.