Recall Z-2531-2020— Philips North America, LLC

Name: FDA recall Z-2531-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-08

Class II · Terminated

Class II FDA medical device recall by Philips North America, LLC, initiated 2020-06-08, terminated 2023-01-09. It names one FDA 510(k) clearance: K993383. Product: Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036). Reason: Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor..

Recalling firm: Philips North America, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-06-08
Terminated: 2023-01-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K993383 — HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.BHewlett-Packard GmbH·cleared 2000-02-03

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

Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)

Reason for recall

Affected M3015A extensions are incompatible with the lntelliVue X3 Patient Monitor (Model No. 867030) and lntelliVue MMX multi-measurement server (Model No. 867036).If they are connected to a host monitor, communication with the X3 or MMX could be disrupted, resulting in a loss of monitoring on the host monitor.

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