Wipro GE Healthcare Private Ltd. is recalling Care Plus and Lullaby incubators due to problems with the door latches, which could lead to newborns falling out of the incubators.
The bedside panel or porthole of the incubators may look closed but may not be latched properly. In addition, if a canopy cover is in place, the bedside panel may look secured, but the panel latches may not be locked correctly.
If the panel detaches or opens, newborns could fall and suffer injuries, such as skin abrasions, bleeding, fractures and head trauma, or death. One serious injury has been reported.
Recalled products include Care Plus, Care Plus models 1000 through 4000, Lullaby Incubator, Lullaby Incubator XP and Lullaby Incubator TR. Model numbers of recalled incubators can be found in a notice from the Food and Drug Administration (FDA).
Wipro GE Healthcare Private Ltd. sent all affected customers a letter on Dec. 26, 2023, explaining actions they can take to continue using the device. They should:
- ensure the latches are secure each time the bedside panel is closed;
- ensure the porthole door latches are checked manually to make sure they are secure each time the porthole doors are closed; and
- ensure the porthole door is pulled to make sure it is latched each time the bedside panel or porthole is closed.
Customers in the U.S. with questions about the recall should call Wipro GE Healthcare Private Ltd. at 800-437-1171.
Health care professionals and consumers can report problems experienced when using these incubators to the FDA’s MedWatch Adverse Event Reporting Program.
