GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 20...
FDA Device Recall #Z-0957-2024 - Class I, December 26, 2023
Recall Summary
| Recall Number | Z-0957-2024 |
| Classification | Class I - Serious risk |
| Date Initiated | December 26, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Wipro GE Healthcare Private Ltd. |
| Location | Bengaluru, N/A |
| Product Type | Devices |
| Quantity | 21626 units |
Product Description
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
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
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
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.