FDA recall Z-0959-2024

Wipro GE Healthcare Private Ltd. · Class I · device

Product

GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

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.

Distribution

Worldwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-12-26
Report date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bengaluru, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2024