Wipro GE Healthcare Private Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0958-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: December 26, 2023

Date Posted: February 21, 2024

Recall Number: Z-0958-2024

Event ID: 93780

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.

Status: Ongoing

Product Quantity: 1410 units

Code Information:

a) Lullaby Incubator, Model Numbers: M1151042, QCR031; b) Lullaby Incubator XP, Model Numbers: 8320, M1151135, QCR034; c) Lullaby Incubator TR, Model Numbers: M1151357 ALL SERIAL NUMBERS

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated