Home › Device types › FMZ
Incubator, Neonatal
FDA product code FMZ · Class 2 · General Hospital
76
Registered devices
847
Adverse events
43
Recalls
86
510(k) clearances
Devices with this code
Giraffe Incubator Carestation — Datex-Ohmeda, Inc.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Connecting Cable(Y) For Dispo Skin Temp Probe — ATOM MEDICAL CORPORATIONTarry Probes — TARRY MEDICAL PRODUCTS, INC.Multi-Link™ — AirLife Finland OyOxyTrace Incu — Drägerwerk AG & Co. KGaADispo Skin Temp Probe(W) (10 pcs/box) — ATOM MEDICAL CORPORATIONIsolette 8000 plus — DRAEGER MEDICAL SYSTEMS, INC.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.AirLife™ — AirLife Finland OyAccess Medical Probes — TARRY MEDICAL PRODUCTS, INC.Airlife — AirLife Finland OyBabyleo TN500 — Drägerwerk AG & Co. KGaAGiraffe OmniBed Carestation — Datex-Ohmeda, Inc.ADVANCED NEONATAL INCUBATOR — ADVANCED INSTRUMENTATIONS, INC.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Tarry Probes — TARRY MEDICAL PRODUCTS, INC.Atom Infant Incubator 101 AC120V w/o O2 Controller Unit — ATOM MEDICAL CORPORATIONTarry Probes — TARRY MEDICAL PRODUCTS, INC.Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set) — ATOM MEDICAL CORPORATIONAtom Infant Incubator 101 AC120V w/O2 Controller Unit — ATOM MEDICAL CORPORATIONGiraffe — Datex-Ohmeda, Inc.AirLife — Carefusion Finland 320 OyAirlife — AirLife Finland Oy
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-01 | GE Medical Systems, LLC | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for examp |
| 2026-05-01 | GE Medical Systems, LLC | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for examp |
| 2026-05-01 | GE Medical Systems, LLC | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for examp |
| 2024-09-03 | DATEX--OHMEDA, INC. | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer |
| 2024-09-03 | DATEX--OHMEDA, INC. | GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | 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 |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | 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 |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | 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 |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | 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 |
| 2023-12-26 | Wipro GE Healthcare Private Ltd. | 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 |
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