Device Recall Philips

  • 모델명 / 제조번호(시리얼번호)
    This action affects certain customers who were shipped an affected Philips Intellivue Information Center unit between June 9, 2008 and May 31, 2009. Affected products have a PC serial number range between 2UA8300XYZ and 2UA84510QW. However, only a subset of these products are affected.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWEDEN SWITZERLAND THAILAND TURKEY UNITED KINGDOM
  • 제품 설명
    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. || The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 229 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Units distributed by Philips Healthcare Inc. and shipped between September 1, 2004 and October 1, 2009.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Class II Recall -- Worldwide Distribution -- United States, Canada, Australia, Brazil, China, France, Germany, Hong Kong, Iceland, India, Indonesia, Italy, Japan, Jordan, Kenya, Libyan Arab Jamahiriya, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Saudi Arabia, Spain, Sri Lanka, Switzerland, Trinidad, Tobago, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Philips HeartStart Vehicle Wall Mount, Model M5528A || with Philips HeartStart DC Power Module, Model M5529A. || The HeartStart MRx portable external defibrillator has optional accessories which include a wall mount and a DC power module. The wall mount is intended for storage and transport of MRx devices in land based transport vehicles. The power module is an additional optional accessory intended to be connected to the wall mount as a means for charging MRx devices (batteries) when stored in the wall mount. The DC power Module is also intended for use with an extension power cable, which is exclusively intended to be used to connect the DC module directly to the MRx. Philips private labels and distributes these devices which are designed and manufactured by Laerdal Medical.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide (US and Puerto Rico). Foreign: Afghanistan Algeria Argentina Australia Austria Bahrain Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Estonia Finland France French Guiana Gabon Germany Greece Guadeloupe Guatemala Hong Kong Hungary Iceland India Indonesia Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea, Republic of Kosovo Kuwait Latvia Lebanon Libyan Arab Jamahiriya Lithuania Luxembourg Macau Malaysia Martinique Mauritius Mexico Moldova Morocco Namibia Netherlands Netherlands Antilles New Caledonia New Zealand Norway Oman Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Qatar Reunion Romania Russia Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Turks and Caicos Islands Ukraine United Arab Emirates United Kingdom Uzbekistan Venezuela Viet Nam Zambia
  • 제품 설명
    Philips Avalon Fetal Monitor FM 50 || Catalog Number: M2705A.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by Philips between September 1, 2008 and December 30, 2008)
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, Estonia, Finland, France, Georgia, Germany, HONG KONG, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Lebanon, Lithuania, Malaysia, Mauritius, Netherlands, NICARAGUA, Norway, Peru, Philippines, POLAND, Portugal, Puerto Rico, Russian Federation, Saudi Arabia, Serbia & Montenegro, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Turkey, UKRAINE, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
  • 제품 설명
    Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) used during open heart surgery. || Models: || M4741A - Extra Large Switched internal Paddles || M4742A - Large Switched internal Paddles || M4743A - Medium Switched internal Paddles || M4744A - Small Switched internal Paddles
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
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US00538342 US00325089 US00331922 US00536598 US00328164 US00211124 US00324004 US00535941 US00327446 US00536188 US00538741 US00536730 US00538423 US00533454 US00327212 US00533456 US00536502 US00535511 US00208426 US00535755 US00538334 US00537880 US00533662 US00535347 US00535843 US00535027 US00332506 US00537317 US00320809 US00318838 US00537754 US00328717 US00328733 US00534261 US00328978 US00206446 US00533636 US00206787 US00537772 US00317961 US00537943 US00207167 US00317265 US00204075 US00330980 US00536230 US00536600 US00329686 US00212772 US00533540 US00206869 US00207074 US00208186 US00323223 US00318239 US00534388 US00329687 US00206160 US00332919 US00322695 US00326795 US00208099 US00206324 US00331582 US00102330 US00535472 US00206039 US00317423 US00331270 US00321927 US00209402 US00535024 US00204408 US00209425 US00537265 US00538821 US00214051 US00538784 US00328999 US00209540 US00213129 US00320269 US00320040 US00533801 US00206156 US00100871 US00328212 US00329685 US00533744 US00327997 US00100939 US00332330 US00202956 US00213535 US00331201 US00208896 US00101640 US00333091 US00317468 US00320152 US00316245 US00537197 US00212574 US00214568 US00535517 US00327289 US00208630 US00208169 US00329001 US00333120 US00100658 US00100941 US00535412 US00323569 US00328934 US00535648 US00534134 US00320612 US00331591 US00327961 US00320602 US00327921 US00534872 US00100155 US00535762 US00208889 US00212329 US00320806 US00536894 US00536271 US00101103 US00535519 US00205108 US00210481 US00322076 US00330599 US00536194 US00534998 US00535440 US00213529 US00203694 US00331236 US00536090 US00329006 US00330985 US00213251 US00101208 US00329398 US00206113 US00327880 US00331231 US00102053 US00101879 US00320208 US00333068 US00317723 US00209974 US00332913 US00321948 US00203674 US00321072 US00323923 US00102107 US00327085 US0021 0270 US00536392 US00209672 US00533770 US00210891 US00213670 US00321306 US00213945 US00202849 US00210262 US00534981 US00323820 US0021 0432 US00102038 US00537768 US00322085 US00316250 US00101100 US00206470 US00212333 US00101922 US00326454 US00204469 US00208504 US00101141 US00208103 US00538774 US00214536 US00331317 US00214998 US00101641 US00213528 US00318774 US00101315 US00203817 US00321076 US00100922 US00534549 US00328168 US00202951 US00316494 US00315087 US00315088 US00101455 US00322701 US00332960 US00206861 US00330076 US00328977 US00536191 US00324550 US00534510 US001 00966 US00319190 US00212662 US00101314 US00538283 US00538786 US00100869 US00214718 US00214470 US00204154 US00536273 US00206483 US00204182 US00318323 US00209124 US00535300 US00212449 US00211 037 US00102512 US00210730 US00315186 US00538696 US00537188 US00101620 US00101203 US00330602 US00327573 US00323406 US00329989 US00537733 US00328134 US00332283 US00538827 US00330020 US00330573 US00209398 US00208917 US00324436 US00536604 US00538778 US00535930 US00318526 US00535082 US00535380 US00320489 US00538719 US00536601 US00538664 US00535765 US00315923 US00318034 US00328786 US00204560 US00536017 US00204403 US00533229 US00213079 US00212023 US00206830 US00101201 US00317052 US00535411 US00317517 US00206256 and US00100830.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide: UNITED STATES, CANADA, AFGHANISTAN, ALBANIA, ,ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM BOSNIA&HERZEGOVINA;, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRI, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NETHERLANDS ANTILLES, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NORWAY, OMAN, PAKISTAN, PALAU, PANAMA, PAPUA NEW GUINEA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM and YEMEN.
  • 제품 설명
    HeartStart MRx Defibrillator Monitor (Models M3535A, M3536A and M3536J) used with Philips 14.8-Volt Lithium Ion Battery (ModeI M3538A). || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    This action affects all customers who were shipped an MRx unit from 2/11/2004 through 06/25/2010
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: CANADA AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOSNIA&HERZEGOVINA; BRAZIL BRUNEI DARUSSALAM BULGARIA CHILE CHINA COLOMBIA CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LEBANON LIBYAN ARAB JAMAHIRI LITHUANIA LUXEMBOURG MACEDONIA MALAYSIA MEXICO MOROCCO NAMIBIA NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIA SAUDI ARABIA SERBIA&MONTE; NEGRO SINGAPORE SLOVENIA SOUTH AFRICA SOUTH KOREA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM VENEZUELA VIET NAM YEMEN
  • 제품 설명
    HeartStart MRx Defibrillator/Monitor || Models: M3535A / M3536A / M3536J / M3536MC || The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
  • Manufacturer
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