FDA Medical Device Recalls (openFDA)
Wipro GE Healthcare Private Ltd.: GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
- Recall number
- Z-0961-2024
- Recalling firm
- Wipro GE Healthcare Private Ltd.
- Product
- GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
- Status
- Open, Classified
- Initiated
- 2023-12-26
- Posted
- 2024-02-09
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling design
- Action
- GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/26/2023 by letter using a traceable means. The notice explained the issued, attached copies of the End of Sales/Service Support letters that were previously distributed, and recommended the replacement of the devices, if possible. 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 pothole is closed, the porthole door is pulled to make sure it is latched. GE HealthCare will provide a user manual addendum, and label for the device, in a future mailing at no cost to you. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Quantity
- 1 unit
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- ALL SERIAL NUMBERS
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMZ
- Firm FEI
- 3007734888
- Firm city
- Bengaluru
- Firm state
- not on file
- Firm country
- India
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28