CLASS II Device recall · Reported 15 Jul 2020 · FDA Enforcement Report

Philips M3015A Microstream CO2 Extension recalled

Philips North America is recalling Philips M3015A Microstream CO2 Extension, distributed nationwide in the US. The recall was initiated on 8 Jun 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUnits with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)

Quantity recalled46,597 Units WW

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2531-2020
FDA event ID: 85799
Recalling firm: Philips North America, Andover, MA
Classification: Class II
Status: Terminated
Recall initiated: 8 Jun 2020
FDA classified: 7 Jul 2020
Reported: 15 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

8 Jun 2020	Recall initiated by company
7 Jul 2020	Classified by FDA	+29 days
15 Jul 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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)

Where it was distributed

Nationwide Foreign: Angola Angola Argentina Australia Austria Bahrain Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Guiana Germany Ghana Gibraltar Greece Greenland Guadeloupe Guatemala Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Martinique Mexico Morocco Mozambique Namibia Netherlands New Caledonia New Zealand Nicaragua Norway Oman Palestine, State of Paraguay Peru Philippines Poland Portugal Qatar R¿union Russian Federation Saint Pierre and Miquelon Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syrian Arab Republic Taiwan Tanzania Thailand Turkey Ukraine United Arab Emirates United Kingdom

Nationwide

Questions about this recall

Is Philips M3015A Microstream CO2 Extension recalled?

Yes. Philips North America recalled Philips M3015A Microstream CO2 Extension on 8 Jun 2020. The recall is Class II and its status is Terminated. Recall number Z-2531-2020.

Why was it recalled?

Which lots are affected?

Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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