Devices

Device Recall Philips Healthcare

  • Model / Serial
    Software versions R5.1.7 and R5.1.8
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Denmark Estonia, Ethiopia. France, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic of, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Palestinian territory, Peru, Poland, Russian Federation, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
  • Manufacturer
    Philips Medical Systems, Inc.
  • 1 Event

Manufacturer

Philips Medical Systems, Inc.
  • Manufacturer Address
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA

79 devices with a similar name

Learn more about the data here

Device Recall Philips Healthcare Brilliance 64
  • Model / Serial
    Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
  • Product Description
    Brilliance 64 with 4.1.7 XX026 software version model number 728231 || Product Usage: || Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Philips Healthcare Brilliance 64
  • Model / Serial
    System Serial Numbers: 10605, 10708, 9208
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
  • Product Description
    Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Philips Healthcare Brilliance 16
  • Model / Serial
    System Serial Numbers: 6147, 6143
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
  • Product Description
    Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Philips Healthcare 16P
  • Model / Serial
    System Serial Numbers: 5380, 5379, 5520, 5524, 5538, 5539, 5549, 5779, 5792, 5778, 5808, 5887, 5888, 5973, 6020, 6026, 6110, 6097, 6352, 6424
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution including US states of CA, MD, NV, OH, TX, and WI, Afghanistan, Canada, Germany, Iraq, Italy, Korea, Kuwait, and Lebanon.
  • Product Description
    Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Philips Healthcare
  • Model / Serial
    Serial Number Range US11149477 - US11149503 US11149741 - US11149795 US11149798 - US11149883 US11149886 - US11149932 US11149935 - US11149959 US11149961 - US11149967 US11150078 - US11150124 US11150162 - US11150177 US11150196 - US11150307 US11150312 - US11150315 US11150336 - US11150343 US11150345 - US11150546
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of ARAB JAMAHIRI, AUSTRIA, AUSTRALIA, BAHRAIN, BANGLADESH, BELGIUM, CANADA ,CHILE, COLOMBIA, CROATIA, CYPRUS, FRANCE, GERMANY, HUNGARY, INDIA, IRELAND, ITALY, KUWAIT, LEBANON, LIBYAN, MALAYSIA, MEXICO, NAMIBIA, NETHERLANDS, NEW ZEALAND, OMAN, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA ,SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Product Description
    Philips SureSigns VM Series Patient Monitors: || VM4, VM6, VM 8: || Model Part Numbers || VM4 863063, 453564024371, 453564021961, 453564024401, 453564021971 || VM6 863064, 863065, 453564024421, 453564022001, 453564024441, 453564022041 || VM8 863066, 863068, 453564022081, 453564024461, 453564024481 || The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 vital signs monitor and VM4, VM6 and VM8 patient monitors are for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
  • Manufacturer
    Philips Healthcare Inc.
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