Agency classClass IOur severity:Severe FDA (Devices)·Z-0959-2024·Announced 2024-02-21

GE Healthcare Care Plus Incubator Hood Latching Defect Increases Fall Risk

GE Healthcare incubator hoods can appear closed but may not be properly latched, posing a fall risk if patients impact an unsecured panel.

The agency’s classification

FDA (Devices): Class I

Class I is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification applies. Although no incidents are currently reported, the agency's designation of Class I indicates a serious hazard with potential for adverse health consequences. The defect involves a failure mode that could result in patient falls.

Plain-English summary

GE Healthcare Care Plus Hood Field Replacement Unit kits, used in Care Plus, Lullaby, and Lullaby XP incubators, can have bedside panels and portholes that appear closed but are not properly latched. The red indicator may be visible even when the panel is not secured, and obstructed portholes may also appear closed while unlatched. Approximately 1,465 units have been distributed worldwide, affecting all serial numbers of the part numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, and 6600-0083-850.

If a patient impacts an unlatched panel or porthole, it can disengage and fall open, removing the protection against patient falls. The FDA has classified this as a Class I recall due to the serious patient safety risk posed by the latching defect.

The recalled product

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
Manufacturer: Wipro GE Healthcare Private Ltd.
Category: Medical Device — Incubator
Hazard: fall-risk
latch-failure
Affected units: 1,465

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

ALL SERIAL NUMBERS

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Wipro GE Healthcare Private Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Wipro GE Healthcare Private Ltd.

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