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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Wipro GE Healthcare Private Ltd.: Neonatal Incubators and Hood Kits Recalled for Latching Failure and Fall Risk

Agency Publication Date: February 9, 2024
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Summary

Wipro GE Healthcare has recalled over 26,000 Care Plus and Lullaby series neonatal incubators and replacement hood kits because the bedside panels and portholes can appear closed but not be fully latched. This defect occurs if a red indicator is visible on the panel or if the portholes are obstructed by items like hood covers. If a patient impacts an unlatched panel or porthole, it can fall open, potentially leading to the infant falling out of the incubator. The recall includes various models manufactured in India and distributed worldwide between December 2023 and the present.

Risk

If the bedside panel or porthole is not securely latched, it may suddenly disengage and fall open if the infant leans against or impacts it. This creates a high risk of the infant falling from the incubator, which can result in serious physical injury or death.

What You Should Do

  1. Check your incubator's model name to see if it is a Care Plus (Models 1000, 2000, 3000, 4000), Lullaby Incubator, Lullaby TR, or Lullaby XP.
  2. Inspect the bedside panels and portholes of the unit; look specifically for a red indicator—if the red indicator is visible, the panel is NOT latched even if it looks upright.
  3. Ensure that no obstructions, such as hood covers, are preventing the portholes from latching properly.
  4. Verify if your facility has purchased 'Field Replacement Unit' (FRU) kits for hoods or doors with part numbers such as 6600-0047-851, 6600-0082-850, or M1169767.
  5. Contact GE HealthCare or your healthcare provider immediately for further technical instructions, safety verification steps, and potential corrective actions.
  6. For additional questions or to report an issue, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Corrective notice and safety instructions via firm letter

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: GE Healthcare neonatal incubator, Care Plus (Various Models)
Model / REF (82):
6600-0040-900
6600-0203-900
6600-0203-903
6600-0232-910
6600-0232-920
6600-0235-901
CARE-PLUS
8200
6600-0264-901
6600-0264-903
6600-0265-901
6600-0265-902
6600-0265-903
6600-0265-908
6600-0266-901
6600-0266-903
6600-0267-901
6600-0269-901
6600-0269-903
6600-0270-901
6600-0272-901
2073175-001
6600-0273-901
6600-0274-901
6600-0274-903
6600-0274-911
6600-0275-901
6600-0275-902
6600-0275-903
6600-0275-908
6600-0275-911
6600-0276-901
6600-0276-903
6600-0277-901
6600-0279-903
6600-0280-901
6600-0280-903
6600-0281-903
6600-0282-901
M1050218
M1160968
M1206249
M1242714
QCR043
6600-0203-902
6600-0223-981
6600-0230-900
6600-0230-901
6600-0232-901
6600-0232-911
Lot Numbers:
ALL SERIAL NUMBERS
Product: GE Healthcare Lullaby Incubator Series
Model / REF:
M1151042
QCR031
8320
M1151135
QCR034
M1151357
Lot Numbers:
ALL SERIAL NUMBERS
Product: Care Plus Hood Field Replacement Unit (FRU) Kit
Model / REF:
6600-0047-851
6600-0033-850
6600-0081-850
6600-0961-500
6600-0083-850
Lot Numbers:
ALL SERIAL NUMBERS
Product: Care Plus Hood Door FRU Kit
Model / REF:
6600-0082-850
6600-0504-800
6600-0148-800
6600-0970-500
Lot Numbers:
ALL SERIAL NUMBERS
Product: Lullaby Incubator Model Hood FRU Kit
Model / REF:
M1169566
M1160659
M1206259
M1206260
M1166836
M1166814
Lot Numbers:
ALL SERIAL NUMBERS
Product: Lullaby Incubator Model Hood Door FRU Kit
Model / REF:
M1169767
M1160674
M1187512
M1206646
M1166822
Lot Numbers:
ALL SERIAL NUMBERS

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93780
Status: Active
Manufacturer: Wipro GE Healthcare Private Ltd.
Sold By: GE HealthCare Authorized Distributors; Direct Sales
Manufactured In: India
Units Affected: 6 products (21626 units; 1410 units; 1465 units; 1810 units; 1 unit; 17 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.