Wipro GE Healthcare Private Ltd. Recalls Care Plus, Care Plus models 1000-4000 and Lullaby Incubators Due to Problems with Door Latch
Please be aware, this recall is a correction, not a product removal.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Names: Care Plus, Care Plus Models 1000 through 4000 and Lullaby Incubator, Lullaby Incubator XP and Lullaby Incubator TR
- Product Codes: FMZ
- Model Numbers:
- All models of Care Plus Hood Field Replacement Unit (FRU) kit: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850
- Care Plus Hood Door FRU kit: 6600-0082-850, 6600-0504-800, 6600-0148-800, 6600-0970-500 M1166822
- All models of Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator
- Lullaby Incubator Model Hood FRU kit: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 and
- Lullaby Incubator Model Hood Door FRU kit: M1169767, M1160674, M1187512, M1206646
- Manufacturing Dates:
- Care Plus, Care Plus models 1000 through 4000: January 1, 1988, to December 31, 2015
- Lullaby Incubator, Lullaby Incubator XP, Lullaby Incubator TR: January 1, 2008, to December 31, 2012
- Distribution Dates:
- Care Plus: January 1, 1988, and December 31, 2015
- Lullaby: January 1, 2008, and December 31, 2021
- Devices Recalled in the U.S.: 15,138
- Date Initiated by Firm: December 26, 2023
Device Use
The Wipro GE Healthcare Private Ltd. Care Plus and Lullaby Incubators are designed to provide heated and humidified air within an enclosed bed compartment for newborns that need support in regulating their body temperature.
Reason for Recall
Wipro Ge Healthcare Private Ltd. is recalling its Care Plus and Lullaby Incubators because the bedside panel or porthole may look closed but not be latched properly. In addition, if a canopy cover is in place, the bedside panel may look secured because the canopy will hold it in a closed position, without the panel latches being locked correctly. If a bedside panel or porthole is not latched properly, the panel can detach and open, no longer protecting the patient from falling.
The use of an affected incubator may lead to falls from the incubator due to improper door closure, and other injuries such as, skin abrasions, bleeding, fractures, and head trauma.
There is one report of serious injury from using this device. No other injuries or deaths have occurred from using this affected device.
Who May be Affected
- Patients inside an affected Wipro Ge Healthcare Private Ltd. Care Plus or Lullaby Incubator
What to Do
On December 26, 2023, Wipro GE Healthcare Private Ltd. sent all affected customers an Urgent Medical Device Correction letter.
The letter provided actions to be taken by the customer for continued use of the device.
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 porthole is closed, the porthole door is pulled to make sure it is latched.
Contact Information
Customers in the U.S. with questions about this recall should contact Wipro GE Healthcare Private Ltd. at 1-800-437-1171.
Additional Resources:
- Medical Device Recall Database Entries
- GE Healthcare Care Plus Hood Door FRU kit
- GE Healthcare Lullaby Incubator Model Hood Door FRU kit
- GE Healthcare neonatal incubator, models: Lullaby Incubator, Lullaby Incubator XP, Lullaby Incubator TR
- GE Healthcare neonatal incubator, models: Care Plus, Care Plus 1000, Care Plus 2000, Care Plus 3000, Care Plus 4000, Plus 4000
- GE Healthcare Lullaby Incubator Model Hood FRU kit
- GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.