FDA recall Z-2697-2020

Philips North America, LLC · Class II · device

Product

IntelliVue MX700 patient monitor, model no. 865241

Reason for recall

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-06-30
Report date
2020-07-29
Termination date
2024-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2697-2020