Events

Recall of Infant Warmer System (IWS)

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

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
    75210
  • Event Risk Class
    Class 2
  • Event Number
    Z-1015-2017
  • Event Initiated Date
    2016-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149672
  • 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
    Warmer, infant radiant - Product Code FMT
  • Reason
    Ge healthcare has recently become aware of a potential safety issue related to loose screws in the heater head of the infant warmer system (iws). hot screws from the heater head of the iws could fall onto the bed if the heater head assembly has been improperly serviced. this situation can be clinically hazardous because thermal injury to a patient could result. two injuries have been reported as a result of this issue.
  • Action
    This recall strategy includes the depth of the recall, plan for public warning and effectiveness check. The strategy outlined below addresses these elements for this particular recall. The plan for public warning is to contact all customers with potentially affected product by means of an Urgent Medical Device Correction letter. The letter will instruct customers that they can continue to use the device by following instructions on the Addendum to the Service Manual. The Service Manual Addendum provides instructions for checking and tightening the screws. In the US the letter will be sent by a traceable means [either US Postal Service with receipt acknowledgement (registered mail) or equivalent courier service such as FEDEX]. This letter will be sent to: Nurse Manager, Labor & Delivery/NICU; Manager, Bio-Medical Engineering; and Director of Risk Management.

Device

Infant Warmer System (IWS)
  • Model / Serial
    Medical device listing number: D103053, D103054, D103056, D103057, D183529
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    This product has been distributed domestically and internationally .
  • Product Description
    Infant Warmer System (IWS)
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA