FDA Medical Device Recalls (openFDA)
Philips North America, LLC: 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)
- Recall number
- Z-2531-2020
- Recalling firm
- Philips North America, LLC
- 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)
- Status
- Terminated
- Initiated
- 2020-06-08
- Posted
- not on file
- Terminated
- 2023-01-09
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 46,597 Units WW
- Distribution
- 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
- Lot, serial or model codes
- Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)
- 510(k) numbers
- ["K993383"]
- PMA numbers
- not on file
- Product code
- DSI
- Firm FEI
- 1218950
- Firm city
- Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28