Alerte De Sécurité sur Trade name: Heated Cradle Technical Name: Heated Cradle Lullaby ANVISA Registration Number: 80071260219 Hazard Class: III Model Affected: Heated Lullaby Cradle Serial numbers affected: Lullaby Heated Cradle (230V) and Lullaby Heated Cradle (115V). 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 must ensure that the bolts are tight as soon as the unit becomes available and there are no patients in the bed. The Maintenance Manual Addendum, shipped with the Urgent Safety Warning Letter, provides instructions for checking and tightening the bolts. During each annual Preventive Maintenance check, the user must continue to make sure the bolts are tight. In addition, GE Healthcare provides instructions on how to correct the problem. You should add this new Addendum to the Maintenance Manual for your devices, and affected users should be trained accordingly. ### Update of the field action: UPDATED ON 10/23/2017, the company presented the report of completion of the field action proving the sending of the safety notice to the client with evidence of science and all actions completed.