Reported Feb 21, 2024 · Ongoing
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e)…
Wipro GE Healthcare Private Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wipro GE Healthcare Private Ltd. · 122 Part 1 · Bengaluru, N/A · N/A
Is this the product you have?
- GE Healthcare neonatal incubator
- models
a) Care Plusb) Care Plus 1000c) Care Plus 2000d) Care Plus 3000e) Care Plus 4000Plus 4000
- Lot codes and dates
- a) Care Plus
- Model Numbers
6600-0040-9006600-0203-9006600-0203-9036600-0232-9106600-0232-9206600-0235-901CARE-PLUSb) Care Plus 1000
- Model Numbers
82006600-0264-9016600-0264-9036600-0265-9016600-0265-9026600-0265-9036600-0265-9086600-0266-9016600-0266-9036600-0267-9016600-0269-9016600-0269-9036600-0270-9016600-0272-901c) Care Plus 2000
- Model Numbers
2073175-0016600-0273-9016600-0274-9016600-0274-9036600-0274-9116600-0275-9016600-0275-9026600-0275-9036600-0275-9086600-0275-9116600-0276-9016600-0276-9036600-0277-9016600-0279-9036600-0280-9016600-0280-9036600-0281-9036600-0282-901M1050218M1160968M1206249M1242714QCR043d) Care Plus 3000
- Model Numbers
231 of 231 codes
6600-0203-9026600-0223-9816600-0230-9006600-0230-9016600-0232-9016600-0232-9116600-0232-9216600-0232-9806600-0232-9836600-0233-9006600-0233-9016600-0233-9116600-0235-9006600-0293-9016600-0293-9036600-0294-9016600-0294-9026600-0294-9036600-0294-9056600-0294-9086600-0294-9096600-0295-9016600-0301-9016600-0301-9036600-0302-9016600-0302-9036600-0303-9016600-0333-9036600-0463-9016600-0511-9016600-0514-9006623-0010-9036623-0010-9236623-0011-9026623-0011-9036623-0011-9206623-0011-9236623-0021-9206623-0111-9006623-0111-9036623-0111-9056623-0311-9006623-0311-9036623-0411-9006623-0411-9056623-0511-9006623-0511-9026623-0511-9036623-0511-9056623-0511-9106623-0511-9136623-0511-9206623-0511-9216623-0511-9436623-0521-9006623-0521-9026623-0521-9056623-0521-9106623-0521-9436623-0610-905
- Model Numbers
211 of 211 codes
6600-0203-9016600-0225-9036600-0232-9006600-0325-9016600-0325-9036600-0326-9016600-0326-9026600-0326-9036600-0326-9046600-0326-9096600-0327-9016600-0333-9016600-0333-9026600-0334-9016600-0334-9026600-0334-9036600-0334-9046600-0334-9056600-0334-9106600-0334-9116600-0421-9006624-0111-9006624-0111-9036624-0311-9006624-0311-9036624-0321-9006624-0321-9036624-0321-9436624-0321-9676624-0411-9006624-0421-9006624-0421-9056624-0511-9006624-0511-9036624-0511-9136624-0521-9006624-0521-9036624-0611-9036624-0621-9026624-0811-9006624-0821-9206624-0821-9436624-0911-9006624-0921-9006624-1021-9006624-1311-9006624-1321-9006624-1321-9036624-1421-9006624-1421-9036624-1511-9006624-1521-9006627-0010-9136627-0011-9036627-0020-9136627-0021-9006627-0021-9036627-0021-9136627-0021-9236627-0110-923
- Amount recalled
- 21626 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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