Recall Z-2696-2020— Philips North America, LLC

Name: FDA recall Z-2696-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-30

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-06-30, terminated 2024-01-25. It names one FDA 510(k) clearance: K150310. Product: IntelliVue MX800 patient monitor, model no. 865240. 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..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-06-30
Terminated: 2024-01-25
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150310 — IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH·cleared 2015-05-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IntelliVue MX800 patient monitor, model no. 865240

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.