Home › Bistos Co., Ltd. › N/A
N/A
Bistos Co., Ltd. · Model BT-500 · UDI-DI 00887529000137
FMZ
Prescription
1
510(k) clearances
888
Adverse events (17 deaths)
43
Recalls
24
Facilities
Description
BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.