GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care
FDA device recall Z-0957-2024 · posted 2024-02-09 · Open, Classified
Recall details
- Recalling firm
- Wipro GE Healthcare Private Ltd.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- FMZ
- Quantity affected
- 21626 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2023-12-26
- Date posted
- 2024-02-09
- Location
- Bengaluru, India
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OHMEDA-OHIO CARE PLUS INCUBATOR (K974349) | Ohmeda Medical | 1998-02-12 |
| OHMEDA-OHIO CAE PLUS INCUBATOR (K962806) | Ohmeda Medical | 1996-09-20 |
| OHIO CARE PLUS INCUBATOR (K943360) | Ohmeda Medical | 1994-09-29 |
| OHIO CARE PLUS INCUBATOR (K914487) | Ohmeda Medical | 1991-12-18 |
| OHMEDA - OHIO(R) CARE PLUS INCUBATOR (K901585) | Ohmeda Medical | 1990-06-22 |
| OHIO(R) CARE PLUS INCUBATOR (K871399) | Ohmeda Medical | 1987-06-05 |