Events

Recall of Device Recall Hydradjust IV DR Urological Table Sedecal Generator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mallinckrodt Inc.

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
    55953
  • Event Risk Class
    Class 2
  • Event Number
    Z-1904-2010
  • Event Initiated Date
    2010-06-14
  • Event Date Posted
    2010-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92315
  • 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
    Generator, high-voltage, x-ray, diagnostic - Product Code IZO
  • Reason
    Covidien received complaints of the sedecal generator failing and producing smoke at customer sites. the failure modes are located in different parts of the generator and will lead to the generator becoming inoperative.
  • Action
    Covidien Issued an "Urgent Device Correction" notification dated June 14, 2010 informing their customers of the potential problem. Consignees were instructed that Field Service Engineers will be in contact arrange a service visit to perform corrections on the affected units. For further information, contact Covidien Product Monitoring at 1-800-778-7898.

Device

Device Recall Hydradjust IV DR Urological Table Sedecal Generator
  • Model / Serial
    Part Number: 750732, Serial Numbers: G28619, G28622, G28623, G28625, G28627, G28630, G28633, G28668, G28669, G28679, G28680, G28924, G28926, G28928, G28930, G28939, G28997, G29001, G29002, G29006, G29028, G29029, G29063, G29064, G29065, G29068, G29069, G29070, G29071, G29138, G29141, G29143, G29151, G29155, G29157, G29162, G29234, G29236, G29238, G29242, G29243, G29248, G29257, G29258, G29261, G29265, G29268, G29277, G29814, G30632, G30635, G30852, G30856, G31123, G31128, G31134, G31344, G31347, G31355, G31359, G31435, G31437, G31439, G31440, G31503, G31505, G31609, G31610, G31612, G31614, G31616, G32275, G32279, G32284, G32288, G32290, G32456, G32461, G32463, G32464, G32468, G32470, G32476, G32511, G32516, G32518, G32520, G32523, G32524, G32537, G32541, G32565, G32566, G32568, G32571, G32578, G32644, G32647, G32649, G32650, G32774, G32776, G32778, G32779, G32786, G32912, G32914, G32915 and G32922; Part Number: 750733, Serial Numbers: G29230, G29891, G30029, G30171, G30172, G30174, G30180, G30322, G30325, G30661, G30666, G30799, G30801, G31007, G31010, G31307, G31310, G315881, G32292, G32535, G32771, G32773, G32918, G-32924, G-32976, G329821, G33085, G33086, G33090, G33361, G33874, G33876, G34118, G34128 and G34232.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada and China.
  • Product Description
    Hydradjust IV DR Urological Table Sedecal Generator (p/n 750732 - 64W generator & p/n 750733 80W generator). Mallinckrodt, Inc. Cincinnati, OH 45237. || Facilitates digital radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation and a flat imaging table.
  • Manufacturer
    Mallinckrodt Inc

Manufacturer

Mallinckrodt Inc
  • Manufacturer Address
    Mallinckrodt Inc, 2111 E Galbraith Rd, Cincinnati OH 45237-1624
  • Source
    USFDA