—#181796

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)

FDA product code: DSI — Detector And Alarm, Arrhythmia
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K993383
Affected lot / code info: Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Philips issued Customer Information Medical Device Correction (CIL86201894B) via priority mail on 6/8/20. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: To check if this issue affects your M3015A, compare the serial number of your device with the affected serial numbers identified; Use affected M3015A extensions only together with an lntelliVue X2 or MMS.; Do not combine an affected M3015A with an lntelliVue X3 or MMX; Philips Healthcare is distributing with this letter an addendum to the Instructions for Use for patient monitors that include directions for the use of the M3015A (MX100/X3, MX400-800 and MX750/MX850). If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Customer Support at 1-800-722-9377.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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

Timeline

Recall initiated: 2020-06-08
Terminated: 2023-01-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181796. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.