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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93780

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 26, 2023
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Wipro GE Healthcare Private Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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

Z-0957-2024
Recall number
Z-0957-2024
Initiated
December 26, 2023
Classification
Class I
Status
Ongoing
Quantity
21626 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

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

Distribution pattern

Worldwide distribution.

device · product 2 of 6

GE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator XP, c) Lullaby Incubator TR

Z-0958-2024
Recall number
Z-0958-2024
Initiated
December 26, 2023
Classification
Class I
Status
Ongoing
Quantity
1410 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

a) Lullaby Incubator, Model Numbers: M1151042, QCR031; b) Lullaby Incubator XP, Model Numbers: 8320, M1151135, QCR034; c) Lullaby Incubator TR, Model Numbers: M1151357 ALL SERIAL NUMBERS

Distribution pattern

Worldwide distribution.

device · product 3 of 6

GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers: 6600-0047-851, 6600-0033-850, 6600-0081-850, 6600-0961-500, 6600-0083-850

Z-0959-2024
Recall number
Z-0959-2024
Initiated
December 26, 2023
Classification
Class I
Status
Ongoing
Quantity
1465 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

ALL SERIAL NUMBERS

Distribution pattern

Worldwide distribution.

device · product 4 of 6

GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500

Z-0960-2024
Recall number
Z-0960-2024
Initiated
December 26, 2023
Classification
Class I
Status
Ongoing
Quantity
1810 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

ALL SERIAL NUMBERS

Distribution pattern

Worldwide distribution.

device · product 5 of 6

GE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659, M1206259, M1206260, M1166836, M1166814

Z-0961-2024
Recall number
Z-0961-2024
Initiated
December 26, 2023
Classification
Class I
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

ALL SERIAL NUMBERS

Distribution pattern

Worldwide distribution.

device · product 6 of 6

GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822

Z-0962-2024
Recall number
Z-0962-2024
Initiated
December 26, 2023
Classification
Class I
Status
Ongoing
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

ALL SERIAL NUMBERS

Distribution pattern

Worldwide distribution.