Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported February 21, 2024
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
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 I…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Wipro Ge Healthcare Private Ltd. recalled GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M116067… - a critical-severity action.
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M116067… was recalled by Wipro Ge Healthcare Private Ltd. in February 21, 2024. Reason: GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 400…. Check the official notice for the remedy. Verify recall #Z-0962-2024 with the FDA Devices before acting.
The recall
Wipro Ge Healthcare Private Ltd. issued this critical-severity FDA Devices recall-GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus¿ Model 1000, 2000, 3000 and 400….
- Critical
- severity level
- 17 units
- affected scope
- Class I
- classification
- February 21, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0962-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0962-2024) was formally reported on February 21, 2024, with the manufacturer initiating the action on December 26, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Wipro Ge Healthcare Private Ltd. is listed as the recalling firm, operating out of Bengaluru, N/A. Federal records list the affected scope as 17 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
17 units
Related Recalls
6
3 from same agency
Product description
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0962-2024 |
| Date reported | February 21, 2024 |
| Date initiated | December 26, 2023 |
| Recalling firm | Wipro Ge Healthcare Private Ltd. |
| Firm location | Bengaluru, N/A |
| Affected scope | 17 units |
| Distribution | Worldwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0962-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822. Recalled by Wipro Ge Healthcare Private Ltd.. Units affected: 17 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2024. Severity: Critical. Recall number: Z-0962-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0962-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 21, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.