GE Healthcare neonatal incubator bedside panels may fail to latch properly
GE Healthcare is recalling neonatal incubators because the bedside panel can appear closed while unlatched. Impact could cause it to fall open, risking patient injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This recall receives a Severe (4) classification because the FDA classified it as a Class I recall. Class I recalls involve products where there is a reasonable probability that use or exposure will cause serious adverse health consequences. Per the rubric, FDA Class I recalls must never be scored below 4, regardless of whether injuries have been reported. No illnesses or injuries are documented in the source text.
Plain-English summary
GE Healthcare is recalling certain neonatal incubator models including Care Plus, Care Plus 1000, Care Plus 2000, Care Plus 3000, Care Plus 4000, Lullaby, Lullaby TR, and Lullaby XP manufactured by Wipro GE Healthcare Private Ltd. Approximately 21,626 units have been distributed worldwide.
The bedside panels and portholes on these incubators can appear closed and latched when they are actually not properly secured. The red indicator light may be visible even when the panel is not latched. Additionally, portholes may appear closed when unlatched, particularly if obstructed by equipment such as hood covers.
If a patient impacts an unlatched bedside panel or porthole, the panel can disengage and fall open, removing the protective enclosure. This poses a risk of patient fall or injury, which is particularly serious in neonatal populations. This is a Class I recall issued by the FDA.
The recalled product
- Product
- GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000
- Manufacturer
- Wipro GE Healthcare Private Ltd.
- Hazard
- fall-risk
- latch-failure
- panel-disengagement
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 (20)
- a) Care Plus
- Model Numbers: 6600-0040-900
- 6600-0203-900
- 6600-0203-903
- 6600-0232-910
- 6600-0232-920
- 6600-0235-901
- CARE-PLUS
- b) Care Plus 1000
- Model Numbers: 8200
- 6600-0264-901
- 6600-0264-903
- 6600-0265-901
- 6600-0265-902
- 6600-0265-903
- 6600-0265-908
- 6600-0266-901
- 6600-0266-903
- 6600-0267-901
- 6600-0269-901
Distribution
Distribution scope not specified by the agency.
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