Device recall: GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e)…
Class I FDA enforcement event 93780. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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…
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Wipro GE Healthcare Private Ltd. started this device recall on 26 Dec 2023. The firm address in the FDA record is in Bengaluru. FDA put the recall in Class I. FDA event 93780 has 6 product records. The first FDA enforcement report date is 21 Feb 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution.
Recalling firm
Wipro GE Healthcare Private Ltd., Bengaluru, N/A, India.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0957-2024 | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000 | 21626 units | Class I | Ongoing | 21 Feb 2024 |
| Z-0958-2024 | GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR | 1410 units | Class I | Ongoing | 21 Feb 2024 |
| Z-0959-2024 | GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850 | 1465 units | Class I | Ongoing | 21 Feb 2024 |
| Z-0960-2024 | GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500 | 1810 units | Class I | Ongoing | 21 Feb 2024 |
| Z-0961-2024 | GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 | 1 unit | Class I | Ongoing | 21 Feb 2024 |
| Z-0962-2024 | GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822 | 17 units | Class I | Ongoing | 21 Feb 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class I
- 10%
- Product records in this event
- 6Median of the firm: 2
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Sep 2025 | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; M | Device | Class II | 2 |
| 9 Aug 2024 | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled | Device | Class II | 2 |
Official channels
- FDA enforcement report Z-0957-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 93780. https://recallregister.com/fda/i/93780/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution.
- What quantity of product is in FDA event 93780?
- The event has 6 product records. The first record gives this quantity:
21626 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 10% of the 917 device events that started in 2023 are in Class I.