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Isolette® 8000 plus
DRAEGER MEDICAL SYSTEMS, INC. · Model MU20602 · UDI-DI 04049098090612
FMZ
Prescription
1
510(k) clearances
847
Adverse events (17 deaths)
43
Recalls
23
Facilities
Description
I8000 plus
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 example, impact during tr |
| 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 example, impact during tr |
| 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 example, impact during tr |
| 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 heaters may not have |
| 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 heaters may not have |
| 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, and Lullaby XP Inc |
| 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, and Lullaby XP Inc |
| 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, and Lullaby XP Inc |
| 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, and Lullaby XP Inc |
| 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, and Lullaby XP Inc |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.