Z-0961-2024Class I

GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260...

Name: Z-0961-2024 GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260...
Creator: Wipro GE Healthcare Private Ltd.
Published: 2023-12-26
License: https://open.fda.gov/license/

Wipro GE Healthcare Private Ltd. / initiated 2023-12-26 / Open, Classified / root cause: labeling and UDI

FDA source

Wipro GE Healthcare Private Ltd. began a recall of GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 on 2023-12-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0961-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-26
Posted: 2024-02-09
Recalling firm: Wipro GE Healthcare Private Ltd.
Product: GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814
Product code: FMZ Incubator, Neonatal
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1 unit
Distribution: Worldwide distribution.
Product codes and lots: ALL SERIAL NUMBERS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0961-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-0958-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-0959-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-0960-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-0961-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-0962-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code FMZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)