Recall Z-0962-2024 ยท FMZ Incubator, Neonatal
Wipro GE Healthcare Private Ltd.
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
| Date | Feb 9, 2024 (initiated Dec 26, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 17 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.