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Recall Observatory FDA recall evidence

Device product

IntelliVue MX700 patient monitor, model no. 865241

Z-2697-2020

June 30, 2020

Class II

Product summary

Firm
Philips North America, LLC
Event
Event 85908
Status
Terminated
Classification
Class II
Quantity
28
Official record key
device-enforcement:Z-2697-2020

Official wording

Reason: 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.

Code information: Serial numbers DE58562415 DE58562344 DE58562353

Distribution pattern: Domestic distribution to CA, HI, MA, NY, and UT. International distribution to Costa Rica, Ireland, Lebanon, and Poland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.