Events

Recall of Diagnost

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems Sales & Service Region No. America.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27013
  • Event Risk Class
    Class 2
  • Event Number
    Z-1212-03
  • Event Initiated Date
    2003-08-10
  • Event Date Posted
    2003-09-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28995
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, Radiographic, Non-Tilting, Powered - Product Code IZZ
  • Reason
    Potential for table to move by itself.
  • Action
    The firm issued a letter dated 8/10/03 informing the consignees of the error and advising that a service employee will be visiting each site for software upgrade.

Device

Diagnost
  • Model / Serial
    Part Number: 9804 405 80001, 9804 405 80101, 9896 000 1284, 9896 000 12851, 9896 000 12451, 9896 000 1262, 9896 000 59041  The firm utilizes a site number specific to each unit: 6993, 62309, 25710, 25901, 62279, 13709, 62635, 76345, 41372, 31000, 17197, 25900, 62300, X0668, 13444, 6981, 6559, 6426, 6583, 38530, 6852, 683, 25907, 44760, 44670, 17368, 17325, 25769, 13951, 13608, 17247, 38507, 26018, 62278, 62391, 17304, 46921, 45014, 45013, 67642, 62404 37859, 86113, 38023, 6541, 74057, 74056, 61667, 62666, 62403, 62310, 35366, 50135, 13971, 25768, 62988, 62885, 38897, 6558, 44699, 76449, 25967, 25884, 25834, 44742, 6935, 40940, 62363, 62362, 38500, X1207, 6539, X1069, 6616, 17436, 59633, 52354, 47166, 17605, 17339, 62504, 62937, 62936, 59497
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed devices to hospitals and medical centers located throughout the U.S.
  • Product Description
    Diagnost 96
  • Manufacturer
    Philips Medical Systems Sales & Service Region No. America

Manufacturer

Philips Medical Systems Sales & Service Region No. America
  • Manufacturer Address
    Philips Medical Systems Sales & Service Region No. America, 22100 Bothell Everett Highway, Bothell WA 98041
  • Source
    USFDA