Events

Recall of Device Recall Rotating IV Pole

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

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
    79452
  • Event Risk Class
    Class 2
  • Event Number
    Z-1181-2018
  • Event Initiated Date
    2017-12-01
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162347
  • 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
    Stand, infusion - Product Code FOX
  • Reason
    There is the potential for the rotating iv pole to fall. a fall could result in an injury to a bystander holding the patient or to the operator.
  • Action
    On December 1, 2017 an URGENT MEDICAL DEVICE CORRECTION letter was issued to customers notifying of the recall. The letter requested customers to discontinue use of the affected Rotating IV poles and remove from Service. Place affected Rotating IV poles in a quarantine marked area. A GE Service Representative will contact you to arrange for the removal & replacement of a new IV pole. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. For further questions, please call (410) 888-5376.

Device

Device Recall Rotating IV Pole
  • Model / Serial
    Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide)
  • Product Description
    Rotating IV Pole || Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.
  • Manufacturer
    Ohmeda Medical

Manufacturer

Ohmeda Medical
  • Manufacturer Address
    Ohmeda Medical, 8880 Gorman Rd, Laurel MD 20723-5800
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA