Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 16, 2024
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America Llc recalled IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and orde… - a moderate-severity action.
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and orde… was recalled by Philips North America Llc in October 16, 2024. Reason: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at t…. Check the official notice for the remedy. Verify recall #Z-0020-2025 with the FDA Devices before acting.
The recall
Philips North America Llc issued this moderate-severity FDA Devices recall-Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at t….
- Moderate
- severity level
- 153 units
- affected scope
- Class II
- classification
- October 16, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0020-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0020-2025) was formally reported on October 16, 2024, with the manufacturer initiating the action on June 14, 2023. 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 153 units OUS.
The documented reason for this recall is: Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Wi… Distribution data in the federal record shows the product reached: Foreign Only: Denmark France Germany Japan United Kingdom. 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
153 units OUS
Related Recalls
6
3 from same agency
Product description
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Reason for recall
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0020-2025 |
| Date reported | October 16, 2024 |
| Date initiated | June 14, 2023 |
| Recalling firm | Philips North America Llc |
| Firm location | Cambridge, MA |
| Affected scope | 153 units OUS |
| Distribution | Foreign Only: Denmark France Germany Japan United Kingdom |
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-0020-2025) 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 MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.. Recalled by Philips North America Llc. Units affected: 153 units OUS.
Why was this product recalled? ▼
Devices with Option CP2 and initially programmed to software version P.01.01 were configured incorrectly at the factory. Therefore, Enhanced ECG Capabilities provided by Option CP2 were not enabled in these devices. Without Option C01 Full Arrhythmia, the device will not provide the yellow alarms for enhanced arrhythmia detection. This is a retrospectively reported recall from 6/14/23.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0020-2025.
Where was the recalled product distributed? ▼
Distribution: Foreign Only: Denmark France Germany Japan United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0020-2025) 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 October 16, 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.