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)
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Philips North America, LLC
- UPC
- Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits)
Units Affected
46,597 Units WW