GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

FDA device recall Z-0958-2024 · posted 2024-02-09 · Open, Classified

Recall details

Recalling firm

Wipro GE Healthcare Private Ltd.

Reason for recall

GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be upright and look closed but not be latched if the red indicator is visible. The portholes also can look closed when not latched when the portholes are obstructed e.g., hood covers. If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open, no longer protecting the patient from falling.

Action taken

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/26/2023 by letter using a traceable means. The notice explained the issued, attached copies of the End of Sales/Service Support letters that were previously distributed, and recommended the replacement of the devices, if possible. Customers who wish to continue using these devices should ensure that: " Each time the bedside panel is closed, the latches are secure. " Each time the porthole doors are closed, the porthole latches are manually checked to make sure the porthole door latches are secure. " Each time the bedside panel or pothole is closed, the porthole door is pulled to make sure it is latched. GE HealthCare will provide a user manual addendum, and label for the device, in a future mailing at no cost to you. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root cause

Labeling design

Status

Open, Classified

Product code

FMZ

Quantity affected

1410 units

Distribution

Worldwide distribution.

Date initiated

2023-12-26

Date posted

2024-02-09

Location

Bengaluru, India