FDA-Device2020-07-29Class II

IntelliVue MX800 patient monitor, model no. 865240

Philips North America, LLC
Hazard

Some Intellivue MX700/MX800 Patient Monitors were delivered with defective power supplies. The defective power supplies might energize the metal parts of monitor if the grounding instructions were not followed, and may also cause the monitor to stop operating or prevent it from being switched on.

Sold states
Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.
Affected count
28
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
IntelliVue MX800 patient monitor, model no. 865240

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2696-2020

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