Events

Recall of Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia 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
    RC-2014-RN-00773-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00773-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Philips healthcare has received a number of complaints about visible mould on gel-e donut and squishon 2 gel-filled products. the mould 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 mould detected on the product has been cladosporium and penicillium fungi, which are commonly found moulds. nicu and picu patients are much more sensitive to moulds and there is potential for the mould to be transferred to these environments once the outer pack is opened.
  • Action
    Users are advised to review their entire inventory of Gel-E Donut and Squishon 2 products and inspect each product for signs of visible mold. Mold should be readily seen as black dots or splotches through the transparent outer packaging. Please do not open the packaging to do the inspection. If unsure or if the inspection is inconclusive, please err on the side of caution and designate that product as containing mold. Dispose of any product containing mold per facility’s environmental guidelines and return unaffected product to their inventory. Customers are also referred to the Instructions for Use, in particular: Wipe all Gel product surfaces with an antibacterial agent and cover the Gel product with a disposable cover or soft cloth before patient use. This action has been closed-out on 17/08/2016.

Device

Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)
  • Model / Serial
    Philips Gel-E Donut and Squishon 2 (Gel filled Pillow)Part numbers: 92025-A, 92025-B, 92025-C (Gel-E Donut) and 91033-2 (Squishon 2)ARTG number: 200647
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA