# FDA recall Z-0959-2024

> **Wipro GE Healthcare Private Ltd.** · Class I · device recall initiated 2023-12-26.

## Product

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

## 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.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-0959-2024
- **Recalling firm:** Wipro GE Healthcare Private Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-26
- **Report date:** 2024-02-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bengaluru, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2024

## Citation

> AI Analytics. FDA recall Z-0959-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0959-2024. Source: US FDA. Licensed CC0.

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