Safety Alert Or Field Safety Notices for Consent decree for medical devices supplied by Atrium Medical (Maquet)

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.

The Food and Drug Administration (FDA), the USA regulator, has identified problems with quality management systems at Maquet and their subsidiaries (including Atrium Medical). Further information can be found on the FDA website. A consent decree has been issued, which prevents one of the USA-based sites from distributing devices.The FDA’s consent decree requires that Atrium Medical’s (Maquet) customers sign a Certificate of Medical Necessity to allow the company to continue the supply of medical devices listed above.The status of other medical devices sold by Atrium Medical (Maquet) is available in Atrium Medical’s Notification Guide.Although the devices listed in the consent decree are CE marked and can be legally sold in the UK, you may be asked to sign a Certificate of Medical Necessity by the manufacturer.