Philips IntelliVue MX40 Patient Monitor Recalled for Manufacturing Defects
Philips is recalling three IntelliVue MX40 patient monitors because manufacturing process failures may have resulted in defective devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential defect that could impact patient safety, but the source text does not report any specific injuries, illnesses, or FDA Class I classification, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling three units of the IntelliVue MX40 Patient Monitor (Model Numbers 865350 and 865352, Software Version B.06.59). The recall was initiated because manufacturing failed to follow required process steps, resulting in the distribution of potentially defective devices.
The affected units were distributed worldwide, specifically in the United States (Indiana and Minnesota) and Italy. The devices are intended for monitoring and recording physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.
Hospitals and healthcare facilities should identify the affected units by checking the serial numbers US09699788, US156J6219, and US156J3658. Affected facilities should contact Philips for instructions on how to proceed with the recall.
The recalled product
- Product
- IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and d
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 3
Distribution
Related recalls
Same manufacturer · Philips North America Llc
See all →- HighPhilips Recalls Cardiac Workstation 5000 Units for Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- HighPhilips Recalls Cardiac Workstation 7000 Due to Inaccurate Heart Rate Data
FDA (Devices) · 2026-08-26
- ModeratePhilips Telemetry Monitor 5500 Device Reset Risk Recall
FDA (Devices) · 2026-07-01
- ModeratePhilips Avalon Fetal Monitor FM20 Speaker Connector Assembly Recall
FDA (Devices) · 2026-07-01
- HighPhilips Avalon Fetal Monitor FM 30 Speaker Connector Assembly
FDA (Devices) · 2026-07-01
Same hazard · defective device
See all →- HighMedline Medical Convenience Kits with Plastic Syringes Recalled Due to Leaks and Breakage
FDA (Devices) · 2024-09-18
- ModerateBeaver Visitec Recalls CustomEyes Procedure Packs with Sol-M Syringes
FDA (Devices) · 2024-09-04
- ModeratePOM Medical Recalls Procedural Oxygen Masks Due to Defective Re-breather Bags
FDA (Devices) · 2019-11-06
- ModerateA&E Medical Thorecon Plating System Kits Recalled for Molding Defect
FDA (Devices) · 2019-11-06
- HighBausch & Lomb Recalls LaserEdge Ophthalmic Knives Due to Dull Blades
FDA (Devices) · 2018-03-14