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.
This recall has been terminated (originally issued February 2, 2021).
- Company
- Philips North America Llc
- Recall Initiated
- February 2, 2021
- Terminated
- September 20, 2022
- Recall Number
- Z-1671-2021
- Quantity
- 3 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices
Distribution
Worldwide distribution - US Nationwide distribution in the states of IN, MN and the country of Italy.
Lot / Code Info
Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658
Root Cause
Employee error
Action Taken
Philips Healthcare conducted site visits on 2/02/21 by Field Service Engineer and provided the customer with RMA to return affected devices. Devices retuned affected device on RMA. Device Replacement provided.
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