Date Initiated by Firm |
June 08, 2020 |
Create Date |
July 10, 2020 |
Recall Status1 |
Terminated 3 on January 09, 2023 |
Recall Number |
Z-2531-2020 |
Recall Event ID |
85799 |
510(K)Number |
K993383
|
Product Classification |
Detector and alarm, arrhythmia - Product Code DSI
|
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)
|
Code Information |
Units with this hardware version can be identified by the following serial number prefix: SN prefix: DE435xxxxx (first five digits) |
Recalling Firm/ Manufacturer |
Philips North America, LLC 3000 Minuteman Rd Andover MA 01810-1032
|
For Additional Information Contact |
Philips Customer Services 800-722-9377
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
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 |
Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = DSI and Original Applicant = HEWLETT-PACKARD GMBH
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