FDA Recall Database: Class I Recall: GE Healthcare Lullaby Incubator Model Hood FRU kit,… by Wipro GE Healthcare Private Ltd.

Key facts

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Wipro GE Healthcare Private Ltd.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Wipro GE Healthcare Private Ltd. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Wipro GE Healthcare Private Ltd. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Wipro GE Healthcare Private Ltd.’s FDA history

Argus HQ has recorded 10 total FDA actions tied to Wipro GE Healthcare Private Ltd.: 0 warning letters, 10 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Is GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Num recalled?

Yes. FDA lists a Class I recall by Wipro GE Healthcare Private Ltd. for GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814, reported 20240221, with status "Ongoing." FDA recall number: Z-0961-2024.

What is the recall class for Wipro GE Healthcare Private Ltd.'s recall?

FDA classified this recall as Class I. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death.

Why was GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Num recalled?

FDA's recall record states 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 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.

Who should I contact about this recall?

Contact Wipro GE Healthcare Private Ltd. directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Related enforcement actions

• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software v… →
• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software v… →
• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmer… →
• Recall: Wipro GE Healthcare Private Ltd. — Class II recall: GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-050… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 66… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767… →
• Recall: Wipro GE Healthcare Private Ltd. — Class I recall: GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby… →