The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2696-2020·Announced 2020-07-29

Philips Recalls IntelliVue MX800 Patient Monitors With Defective Power Supplies

Philips is recalling 28 IntelliVue MX800 patient monitors due to defective power supplies that may energize metal parts or prevent operation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 risk-of-harm product (electrical shock/energized metal parts) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Philips North America, LLC is recalling 28 units of the IntelliVue MX800 patient monitor, model no. 865240. The recall is due to defective power supplies that were delivered with the devices.

The defective power supplies might energize the metal parts of the monitor if grounding instructions were not followed. Additionally, the defect may cause the monitor to stop operating or prevent it from being switched on.

The affected units were distributed domestically to California, Hawaii, Massachusetts, New York, and Utah, as well as internationally to Costa Rica, Ireland, Lebanon, and Poland. Specific serial numbers are listed in the official recall record. Users should contact Philips for instructions on how to address the defect.

The recalled product

Product
IntelliVue MX800 patient monitor, model no. 865240
Affected units
28

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 2 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Philips North America, LLC

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