Recall Z-0957-2024— Wipro GE Healthcare Private Ltd.
Class I · Ongoing
Class I FDA medical device recall by Wipro GE Healthcare Private Ltd., initiated 2023-12-26. It names 6 FDA 510(k) clearances: K974349, K962806, K943360 and 3 more. 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. 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..
- Recalling firm
- Wipro GE Healthcare Private Ltd.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-12-26
- Firm location
- Bengaluru, N/A, India
510(k) clearances named in this recall
6 on FDA's record- K974349 — OHMEDA-OHIO CARE PLUS INCUBATOR
- K962806 — OHMEDA-OHIO CAE PLUS INCUBATOR
- K943360 — OHIO CARE PLUS INCUBATOR
- K914487 — OHIO CARE PLUS INCUBATOR
- K901585 — OHMEDA - OHIO(R) CARE PLUS INCUBATOR
- K871399 — OHIO(R) CARE PLUS INCUBATOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.