Devices

Device Recall Philips

  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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
  • Product Description
    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
    Philips Electronics North America Corporation
  • 1 Event

Manufacturer

Philips Electronics North America Corporation
  • Manufacturer Address
    Philips Electronics North America Corporation, 3000 Minuteman Rd, Andover MA 01810-1032
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA

229 devices with a similar name

Learn more about the data here

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 Brilliance Big Bore Radiology 728244
  • Model / Serial
    UDI: (01)00884838059450(21)76064, Serial Number: 76064;  UDI: (01)00884838059450(21)76102, Serial Number: 76102;  UDI: (01)00884838059450(21)76094, Serial Number: 76094
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
  • Product Description
    Brilliance Big Bore Radiology 728244
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Philips Ingenuity Core 728321
  • Model / Serial
    UDI: (01)00884838059498(21)333169, Serial Number: 333169;  UDI: (01)00884838059498(21)310377, Serial Number: 310377;  UDI: (01)00884838059498(21)310375, Serial Number: 310375;  UDI: (01)00884838059498(21)333171, Serial Number: 333171;  UDI: (01)00884838059498(21)333172, Serial Number: 333172
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.
  • Product Description
    Philips Ingenuity Core 728321
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
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