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Recall Observatory FDA recall evidence

Device product

IntelliVue MX800 patient monitor, model no. 865240

Z-2696-2020

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-2696-2020

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 DE50887321 DE50887434 DE50887128 DE50887025 DE50887196 DE50887429 DE50887125 DE50887043 DE50887303 DE50887420 DE50887106 DE50887164 DE50887322 DE50887607 DE50887061 DE50887179 DE50887425 DE50887427 DE50887142 DE50887446 DE50887152 DE50887064 DE50887445 DE50887137 DE50887063

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.