Agency classClass IOur severity:Severe FDA (Devices)·Z-0960-2024·Announced 2024-02-21

GE Healthcare incubator bedside panel may disengage and fall open

The bedside panel on GE Healthcare Care Plus incubators may appear closed while unlatched. If impacted, the panel can fall open, exposing patients to injury risk.

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: This is an FDA Class I recall of a critical medical device protecting vulnerable neonatal patients. The hazard is a structural latching failure that could result in the protective panel falling open and exposing patients to injury from falling, representing a serious risk of harm.

Plain-English summary

GE Healthcare is recalling the Care Plus Hood Door FRU kit (part numbers 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500) used in Care Plus Model 1000, 2000, 3000, and 4000 Incubators, as well as Lullaby, Lullaby TR, and Lullaby XP Incubators. The bedside panel can remain unlatched while appearing to be closed, especially when the red indicator is visible or when portholes are obstructed.

If a patient impacts the bedside panel or porthole that is not latched, the panel can disengage and fall open. This loss of the protective barrier exposes the patient to the risk of falling.

The recall affects approximately 1,810 units distributed worldwide. Affected facilities should immediately verify that all incubator panels and portholes are properly latched before patient use and contact GE Healthcare with any questions or concerns.

The recalled product

Product: GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
Manufacturer: Wipro GE Healthcare Private Ltd.
Category: Medical Device — Neonatal Incubators
Hazard: structural-failure
latching-failure
fall-risk
patient-injury-risk
Affected units: 1,810

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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Same hazard · structural failure