IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with...
FDA Device Recall #Z-0020-2025 — Class II — June 14, 2023
Recall Summary
| Recall Number | Z-0020-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 14, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips North America Llc |
| Location | Cambridge, MA |
| Product Type | Devices |
| Quantity | 153 units OUS |
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.
Distribution Pattern
Foreign Only: Denmark France Germany Japan United Kingdom
Lot / Code Information
UDI-DI: (01)00884838038769(21); (01)00884838038776(21); (01)00884838038783(21 Serial Numbers: DE7580BB1Y DE7580BB1Z DE7580BB20 DE7580BB21 DE7580BB22 DE7580BB23 DE7580BB24 DE7580BB25 DE7580BC47 DE7580BC48 DE7580BC4L DE7580BC4M DE7580BC4N DE7580BC4P DE7580BC4T DE7580BC4U DE7580BC5K DE7580BC5L DE7580BC5N DE7580BC5P DE7580BC5R DE7580BC5T DE7580BC5U DE7580BC5V DE7580BC68 DE7580BC69 DE7580BC6A DE7580BC6B DE7580BC6C DE7580BC6D DE7580BC6E DE7580BC6R DE7580BC6Z DE7580BC8R DE7580BCV4 DE7580BD4K DE7580BD4L DE7580BF3Z DE7580BFUL DE7580BFUM DE7580BFUN DE7580BFWY DE7580BJM2 DE7580BJM3 DE7580BJM4 DE7580BJM5 DE7580BJM6 DE7580BJM7 DE7580BJWV DE7580BJWW DE7580BJWY DE7580BJWZ DE7580BJY0 DE7580BJY1 DE7580BK55 DE7580BK56 DE7580BK75 DE7580BK76 DE7580BK77 DE7580BK78 DE7580BK79 DE7580BK7A DE7580BK7B DE7580BK7C DE7580BK7D DE7580BK7E DE7580BC3A DE7580BC3B DE7580BC3C DE7580BC3E DE7580BC3F DE7580BC3G DE7580BC3H DE7580BC3J DE7580BC3K DE7580BC3L DE7580BC3M DE7580BC3N DE7580BC3R DE7580BC3T DE7580BC3U DE7580BC3V DE7580BC3W DE7580BC3Y DE7580BC3Z DE7580BC40 DE7580BC41 DE7580BC42 DE7580BC43 DE7580BC75 DE7580BC79 DE7580BCY8 DE7580BCY9 DE7580BCYA DE7580BCYB DE7580BCYD DE7580BCYE DE7580BCYF DE7580BCYG DE7580BCYK DE7580BCYL DE7580BDE4 DE7580BDE5 DE7580BDE6 DE7580BDE7 DE7580BE0K DE7580BE0L DE7580BEWY DE7580BHZT DE7580BNKB DE7580BNKC DE7580BNKD DE7580BNKE DE7580BBBA DE7580BBUE DE7580BBUK DE7580BBUL DE7580BBUY DE7580BBUZ DE7580BBV0 DE7580BBV1 DE7580BBVC DE7580BBVD DE7580BBVE DE7580BBVF DE7580BBVU DE7580BBVV DE7580BBVY DE7580BBW9 DE7580BBWA DE7580BBWB DE7580BBWC DE7580BBWP DE7580BBWR DE7580BBYR DE7580BC2E DE7580BC2F DE7580BC2G DE7580BC2H DE7580BC2M DE7580BC2N DE7580BC2P DE7580BC2R DE7580BC2T DE7580BC2U DE7580BC2V DE7580BC2W DE7580BC2Y DE7580BC2Z DE7580BFVB DE7580BK89 DE7580BK8A DE7580BK8B
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| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1316-2026 | Class II | IQon Spectral CT; Product Code (REF): 728332; | Jan 7, 2026 |
| Z-1318-2026 | Class II | Spectral CT 7500 on Rails; Product Code (REF):... | Jan 7, 2026 |
| Z-1317-2026 | Class II | Spectral CT; Product Code (REF): 728333; | Jan 7, 2026 |
| Z-1315-2026 | Class II | Brilliance iCT; Product Code (REF): 728306; | Jan 7, 2026 |
| Z-1033-2026 | Class II | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient M... | Dec 12, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.