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 during transport inside hospitals.
Reported: June 2, 2021 Initiated: February 2, 2021 #Z-1671-2021
Product Description
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 during transport inside hospitals.
Reason for Recall
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Details
- Recalling Firm
- Philips North America Llc
- Units Affected
- 3 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
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 during transport inside hospitals.. Recalled by Philips North America Llc. Units affected: 3 units.
Why was this product recalled? ▼
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 2, 2021. Severity: Moderate. Recall number: Z-1671-2021.
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