Events

Recall of GEL-E DONUT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

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
    31261
  • Event Risk Class
    II
  • Event Initiated Date
    2014-06-02
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware that mold has been found on some gel-e donut and squishon 2 gel-filled products. the mold manifests as small black markings on the outer surface of the gel-e donut and squishon pad which are visible through the transparent outer packaging. the mold detected ont eh product has been cladosporium and penicillium fungi which are commonly found molds.

Device

GEL-E DONUT
  • Model / Serial
    Model Catalog: 92025-B (Lot serial: >1000 numbers contact mfg.); Model Catalog: 92025-C (Lot serial: >1000 numbers contact mfg.); Model Catalog: 92025-A (Lot serial: >1000 numbers contact mfg.); Model Catalog: 91033-2 (Lot serial: >100 numbers contact mfg.)
  • Product Description
    Gel-E Donut
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC