Device Recall Philips

  • Model / Serial
    Serial Numbers 525 539 146 155 171 173 178 611 612 150 165 231 234 175 235 236 237 238 239 240 356 376 389 414 000475 483 000496 502 510 511 686 693 700 723 724 725 167-000385 167-000487 232 000372, and 000834.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
  • Product Description
    FloTrak Elite modules || FloTrak Elite P/N 1044971 || FloTrak Elite P/N 1051005
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Respironics Novametrix, LLC., 5 Technology Dr, Wallingford CT 06492-1942
  • Source
    USFDA

229 devices with a similar name

Learn more about the data here

  • Model / Serial
    Software release: PBL 6.1.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution (USA) including the states of AR, AZ, CA, CO, FL, IA, KS, LA, MI, MO, NC, NY, OH, PA, TX, VA, VT, WA and WV
  • Product Description
    Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 || Product Code 708037 || Product Usage: || The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. General R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive system, Skeletal system, Urinary system, Reproductive system, Respiratory system, Circulatory system, and Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
  • Manufacturer
  • Model / Serial
    MultiDiagnost Eleva II - 708036, 708032,  MultiDiagnost Eleva FD - 708037, 708034,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Product Description
    Philips Healthcare MD Eleva system. || Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
  • Manufacturer
  • Model / Serial
    Software release 4.0.0
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland.
  • Product Description
    Philips Intellispace Portal, Release 4.0.0. || For storing, processing and management of electronic information/data || Model: 881001. || Indicated for use as a diagnostic device.
  • Manufacturer
  • Model / Serial
    Models with SW Revision H (up to and including H.15.36) are affected, upgraded between October 6, 2010 and January 23, 2012  MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600 (865242), MX700 (865241) MX800 (865240
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide) and the countries of ALBANIA, ANGOLA, ANTILLES, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BYELORUSSIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, EGYPT, ESTONIA, FINLAND, FRANCE, GABON, GERMANY, GHANA, GREECE, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LEBANON, LIBYAN, ARAB, JAMAHIRI, LITHUANIA, LUXEMBOURG,MACAU, MALAYSIA, MOROCCO, MAURITIUS, MEXICO, MOROCCO, NAMIBIA, NEPAL, NETHERLANDS, ANTILLES, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PALESTINE, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UKRAINE, UNITED ARAB, EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIET NAM, YEMEN, ARAB REP and ZAMBIA
  • Product Description
    Philips IntelliVue Patient Monitors: || The monitor is intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in health care facilities. The monitor is to be used by trained health care professionals. Physiological Monitoring, Patient Monitor , Arrhythmia detector and alarm (including ST -segment measurement and alarm.
  • Manufacturer
  • Model / Serial
    DRF systems with software reI 3.0 and 3.1 S/N: 362600 362601 364209 364210 375245 375850 376439 416254/SN09000007 417890/SN08000120 384396 401281/SN08000142 399440 387492 399621 398185 423047 399623 422094 422823 412477/SN08000137 425981 402409 402410/SN08000112 428620 428623 426466 426467 404548/SN08000110 417116/SN08000126 410563/SN08000120 408593/SN08000103 408592/SN08000111 408237/SN08000115 409087/SN08000107 435412 413514/SN08000123 413831/SN08000122 422648 422650 422652 414463 416393/SN08000140 416643/SN09000005 420212 421780 420872/SN09000003 425745 425744 427503 435926 430916 H706034090029 429498 431820 435419 439922 432277 435422
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    Philips EasyDiagnost Eleva DRF, Fluoroscopic x-ray system || Software Release 3.0 and 3.1 || Model: 706034 || Product Usage: Radiological image processing system (computed radiography x-ray system)
  • Manufacturer
224 more