GE Healthcare neonatal incubator recall
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
Why was GE Healthcare neonatal incubator recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 6600-0269-903, 6600-0270-901, 6600-0272-901; c) Care Plus 2000, Model Numbers: 2073175-001, 6600-0273-901, 6600-0274-901, 6600-0274-903, 6600-0274-911, 6600-0275-901, 6600-0275-902, 6600-0275-903, 6600-0275-908, 6600-0275-911, 6600-0276-901, 6600-0276-903, 6600-0277-901, 6600-0279-903, 6600-0280-901, 6600-0280-903, 6600-0281-903, 6600-0282-901, M1050218, M1160968, M1206249, M1242714, QCR043; d) Care Plus 3000, Model Numbers: 6600-0203-902, 6600-0223-981, 6600-0230-900, 6600-0230-901, 6600-0232-901, 6600-0232-911, 6600-0232-921, 6600-0232-980, 6600-0232-983, 6600-0233-900, 6600-0233-901, 6600-0233-911, 6600-0235-900, 6600-0293-901, 6600-0293-903, 6600-0294-901, 6600-0294-902, 6600-0294-903, 6600-0294-905, 6600-0294-908, 6600-0294-909, 6600-0295-901, 6600-0301-901, 6600-0301-903, 6600-0302-901, 6600-0302-903, 6600-0303-901, 6600-0333-903, 6600-0463-901, 6600-0511-901, 6600-0514-900, 6623-0010-903, 6623-0010-923, 6623-0011-902, 6623-0011-903, 6623-0011-920, 6623-0011-923, 6623-0021-920, 6623-0111-900, 6623-0111-903, 6623-0111-905, 6623-0311-900, 6623-0311-903, 6623-0411-900, 6623-0411-905, 6623-0511-900, 6623-0511-902, 6623-0511-903, 6623-0511-905, 6623-0511-910, 6623-0511-913, 6623-0511-920, 6623-0511-921, 6623-0511-943, 6623-0521-900, 6623-0521-902, 6623-0521-905, 6623-0521-910, 6623-0521-943, 6623-0610-905, 6623-0611-900, 6623-0611-903, 6623-0611-905, 6623-0611-943, 6623-0621-943, 6623-0711-900, 6623-0711-903, 6623-0711-920, 6623-0811-900, 6623-0811-903, 6623-0811-910, 6623-0811-913, 6623-0811-920, 6623-0811-943, 6623-0911-900, 6623-0911-905, 6623-0921-905, 6623-1011-903, 6623-1411-900, 6623-1421-905, 6623-1511-900, 6626-0010-903, 6626-0010-913, 6626-0010-923, 6626-0011-900, 6626-0011-902, 6626-0011-903, 6626-0011-905, 6626-0011-920, 6626-0011-923, 6626-0021-903, 6626-0111-900, 6626-0121-905, 6626-0121-920, 6626-0211-900, 6626-0221-900, 6626-0221-903, 6626-0311-900, 6626-0311-902, 6626-0311-903, 6626-0311-905, 6626-0311-910, 6626-0321-900, 6626-0411-900, 6626-0411-903, 6626-0411-905, 6626-0411-920, 6626-0421-900, 6626-0421-913, 6626-0421-920, 6626-0510-900, 6626-0510-905, 6626-0511-900, 6626-0511-901, 6626-0511-902, 6626-0511-903, 6626-0511-905, 6626-0511-910, 6626-0511-913, 6626-0511-920, 6626-0511-922, 6626-0511-923, 6626-0521-900, 6626-0521-902, 6626-0521-903, 6626-0521-905, 6626-0521-913, 6626-0521-920, 6626-0521-923, 6626-0610-923, 6626-0611-900, 6626-0611-903, 6626-0611-905, 6626-0611-920, 6626-0611-923, 6626-0621-903, 6626-0710-903, 6626-0711-900, 6626-0711-903, 6626-0711-905, 6626-0810-923, 6626-0811-900, 6626-0811-902, 6626-0811-903, 6626-0811-904, 6626-0811-905, 6626-0811-920, 6626-0811-923, 6626-0821-900, 6626-0821-903, 6626-0821-920, 6626-0911-900, 6626-0911-902, 6626-0911-903, 6626-0911-905, 6626-0911-923, 6626-0921-902, 6626-0921-903, 6626-0921-905, 6626-1011-900, 6626-1111-905, 6626-1421-905, 6626-1511-900, 6626-1521-900, 6626-1611-920, 6626-1811-900, 6628-0011-900, 6628-0011-903, 6628-0011-913, 6628-0021-903, 6628-0111-900, 6628-0111-903, 6628-0211-900, 6628-0221-900, 6628-0311-900, 6628-0321-900, 6628-0321-910, 6628-0411-900, 6628-0411-902, 6628-0411-903, 6628-0421-900, 6628-0511-900, 6628-0511-920, 6628-0511-923, 6628-0511-943, 6628-0521-943, 6628-0610-923, 6628-0611-900, 6628-0611-903, 6628-0611-905, 6628-0621-900, 6628-0711-905, 6628-0721-905, 6628-0810-923, 6628-0811-900, 6628-0811-902, 6628-0811-903, 6628-0811-905, 6628-0811-910, 6628-0811-920, 6628-0811-922, 6628-0820-923, 6628-0821-900, 6628-0821-903, 6628-0910-900, 6628-0911-900, 6628-0911-903, 6628-0911-905, 6628-0921-902, 6628-0921-920, 6628-1321-920, 6628-1421-903, 6628-1521-920, M1050214, M1051981, M1052131, M1052601, M1053655, M1053786, M1054018, M1056216, M1056217, M1061559, M1117929, M1136797, M1137588, M1137746, M1137750, QCR045; e) Care Plus 4000, Plus 4000, Model Numbers: 6600-0203-901, 6600-0225-903, 6600-0232-900, 6600-0325-901, 6600-0325-903, 6600-0326-901, 6600-0326-902, 6600-0326-903, 6600-0326-904, 6600-0326-909, 6600-0327-901, 6600-0333-901, 6600-0333-902, 6600-0334-901, 6600-0334-902, 6600-0334-903, 6600-0334-904, 6600-0334-905, 6600-0334-910, 6600-0334-911, 6600-0421-900, 6624-0111-900, 6624-0111-903, 6624-0311-900, 6624-0311-903, 6624-0321-900, 6624-0321-903, 6624-0321-943, 6624-0321-967, 6624-0411-900, 6624-0421-900, 6624-0421-905, 6624-0511-900, 6624-0511-903, 6624-0511-913, 6624-0521-900, 6624-0521-903, 6624-0611-903, 6624-0621-902, 6624-0811-900, 6624-0821-920, 6624-0821-943, 6624-0911-900, 6624-0921-900, 6624-1021-900, 6624-1311-900, 6624-1321-900, 6624-1321-903, 6624-1421-900, 6624-1421-903, 6624-1511-900, 6624-1521-900, 6627-0010-913, 6627-0011-903, 6627-0020-913, 6627-0021-900, 6627-0021-903, 6627-0021-913, 6627-0021-923, 6627-0110-923, 6627-0111-900, 6627-0111-905, 6627-0111-920, 6627-0121-900, 6627-0121-903, 6627-0121-920, 6627-0211-900, 6627-0221-900, 6627-0221-903, 6627-0221-905, 6627-0221-910, 6627-0311-900, 6627-0311-903, 6627-0311-905, 6627-0320-903, 6627-0320-913, 6627-0321-900, 6627-0321-902, 6627-0321-903, 6627-0321-910, 6627-0321-923, 6627-0321-966, 6627-0321-967, 6627-0411-900, 6627-0411-903, 6627-0421-900, 6627-0421-902, 6627-0421-903, 6627-0421-905, 6627-0421-910, 6627-0421-913, 6627-0421-920, 6627-0421-966, 6627-0421-967, 6627-0511-900, 6627-0511-903, 6627-0511-920, 6627-0511-923, 6627-0521-900, 6627-0521-903, 6627-0521-913, 6627-0521-920, 6627-0521-923, 6627-0610-923, 6627-0611-900, 6627-0611-903, 6627-0621-903, 6627-0711-900, 6627-0811-900, 6627-0811-903, 6627-0811-905, 6627-0820-913, 6627-0821-900, 6627-0821-923, 6627-0911-900, 6627-0911-903, 6627-0911-905, 6627-0911-910, 6627-0921-900, 6627-0921-903, 6627-1011-903, 6627-1021-903, 6627-1121-922, 6627-1311-900, 6627-1321-900, 6627-1321-903, 6627-1321-910, 6627-1321-966, 6627-1411-900, 6627-1411-920, 6627-1421-900, 6627-1421-903, 6627-1421-905, 6627-1421-910, 6627-1421-920, 6627-1421-953, 6627-1511-900, 6627-1921-900, 6629-0011-900, 6629-0011-905, 6629-0021-900, 6629-0021-903, 6629-0021-943, 6629-0110-923, 6629-0111-900, 6629-0121-900, 6629-0121-910, 6629-0121-923, 6629-0211-900, 6629-0221-900, 6629-0221-910, 6629-0310-923, 6629-0311-900, 6629-0311-903, 6629-0320-913, 6629-0320-923, 6629-0321-900, 6629-0321-903, 6629-0321-910, 6629-0321-913, 6629-0321-920, 6629-0321-923, 6629-0411-900, 6629-0411-903, 6629-0411-905, 6629-0420-913, 6629-0421-900, 6629-0421-902, 6629-0421-903, 6629-0421-910, 6629-0421-913, 6629-0511-900, 6629-0511-903, 6629-0521-900, 6629-0521-902, 6629-0610-923, 6629-0611-900, 6629-0611-910, 6629-0620-923, 6629-0711-900, 6629-0711-910, 6629-0810-923, 6629-0811-900, 6629-0811-902, 6629-0811-903, 6629-0811-923, 6629-0820-923, 6629-0821-900, 6629-0821-902, 6629-0821-903, 6629-0821-920, 6629-0821-923, 6629-0911-900, 6629-0920-903, 6629-0920-923, 6629-0921-900, 6629-0921-902, 6629-0921-905, 6629-1311-900, 6629-1321-900, 6629-1321-903, 6629-1411-900, 6629-1421-900, 6629-1421-903, 6629-1421-920, 6629-1511-900, M1052135, M1052600, M1053785, M1137897; ALL SERIAL NUMBERS
- 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
- Recalling firm
- Wipro GE Healthcare Private Ltd.
- Quantity
- 21626 units
- Distribution
- Worldwide distribution.
- Recall date
- February 21, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)