Events

Recall of Device Recall Healthwear

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

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
    31836
  • Event Risk Class
    Class 3
  • Event Number
    Z-1113-05
  • Event Initiated Date
    2005-05-03
  • Event Date Posted
    2005-08-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38597
  • 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
    unknown device name - Product Code LYW
  • Reason
    Lack of adequate manufacturing controls.
  • Action
    Consignees were notified via letter dated 5/3/05. Customers were requested to discard their device and to respond to Roche for a refund. The firm''s internet support site for the system is being turned off.

Device

Device Recall Healthwear
  • Model / Serial
    All units.
  • Distribution
    Nationwide.
  • Product Description
    Roche Diagnostic HealthWear brand Professional System for weight management; Catalog # 04344456001.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA