Home / Recalls / Philips North America, LLC / Z-2531-2020

Z-2531-2020 Class II Terminated

Recalled by Philips North America, LLC — Andover, MA

FDA device recall Z-2531-2020 was initiated by Philips North America, LLC on June 8, 2020 and is designated Class II. 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 mon… The recall status is terminated (terminated January 9, 2023). Affected quantity: 46,597 Units WW.

Recall Details

Product Type: Devices
Report Date: July 15, 2020
Initiation Date: June 8, 2020
Termination Date: January 9, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 46,597 Units WW

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.

Distribution Pattern

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

Code Information

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

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