Philips North America Llc: 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 gen

Is my product affected?

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 insi

• UPC 00884838082236
• UPC 00884838030350

Check against the official notice below — it lists the full affected range.

What happened

Philips North America has recalled three units of the IntelliVue MX40 Patient Monitor (model numbers 865350 for US distribution and 865352 for outside US) with software version B.06.59 due to manufacturing process failures that resulted in potentially defective devices being distributed. The affected units have serial numbers US09699788, US156J6219, and US156J3658, and were distributed in the US states of Indiana and Minnesota, as well as Italy.

The source document does not specify a remedy or what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Manufacturing failed to follow process steps resulting in the distribution of potentially defective devices

Details from the source

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. Quantity: 3 units Lot/code info: Serial numbers: US09699788 (US) US156J6219 (US) US156J3658 (OUS) UDI: (01)00884838082236 (21)US09699788 (01)00884838082236 (21)US156J6219 (01)00884838030350 (21)US156J3658

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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