Alerte De Sécurité sur Trade name: GIRAFFE INCUBATOR Technical name: Neonatal incubator ANVISA registration number: 80035360042 Hazard class: III Model affected: GIRAFFE OMNIBED / GIRAFFE INCUBATOR Serial numbers affected: "Taller Bridge" power cables manufactured by Electri-Cord. View the Product Images in the Urgent Security Notice Letter to check the images of Affected and Non-Affected products.

Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.

The user should check if any of the power cables follow the Electri-Cord "Taller Bridge" model is in use on one of the listed GE products. During the check, the power cord should also be inspected for damage or excessive wear and tear. If any power cables with bent or cracked tips, burned plastic or excessive wear and tear are found, use should be stopped immediately and the power cord should be discarded. If there is no sign of damage, the customer can continue to use the power cord until the replacement occurs. In order to receive corrected power cables, the medical device correction confirmation form must be completed, attached to the letter sent to the customer. The customer can refer to the form for instructions on completing and forwarding the shipment to GE Healthcare. The form must be sent to GE Healthcare within 2 weeks of receipt of the letter. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the report of completion of the field action attesting that there was no affected product in the country.