Wipro GE Healthcare Private Ltd. Recall 93780
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
Wipro GE Healthcare Private Ltd. Recall 93780 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0957-2024 |
| Event ID | 93780 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 21626 units |
| Recall Reason | 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. |
| Device Classification | 20240221 |
| Device Code Info | 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 |
| Center Classification Date | 20240209 |
| Recall Initiation Date | 20231226 |
| Recalling Firm | Wipro GE Healthcare Private Ltd. |
| Initial Notification | Letter |
| Similar To |