Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0962-2024 — GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

U.S. FDA — Device Enforcement · India · 2023-12-26 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0962-2024
Date of alert
2023-12-26
Country / jurisdiction
India
Risk level
Class I
Risk type
recall
Brand
Wipro GE Healthcare Private Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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