GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-00
FDA device recall Z-0141-2025 · posted 2024-10-31 · Completed
Recall details
- Recalling firm
- DATEX--OHMEDA, INC.
- Reason for recall
- Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
- Action taken
- GE HealthCare notified its consignees of the issue by letter beginning on 06/06/2023 using a traceable means. The notice explained the issue of potentially higher levels of formaldehyde which rapidly decrease of a week, and instructions on how to accelerate the rate of dissipation if the unit had not yet been put into clinical use. For questions: contact 1-800-437-1171 or your local GE HealthCare Representative
- Root cause
- Component design/selection
- Status
- Completed
- Product code
- FMZ
- Quantity affected
- 224 units
- Distribution
- worldwide
- Date initiated
- 2023-06-06
- Date posted
- 2024-10-31
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Giraffe Incubator Carestation CS1 (K213553) | Datex Ohmeda, Inc. | 2022-03-02 |
| Giraffe Incubator Carestation CS1 (K152809) | Ohmeda Medical, A Division of Datex-Ohmeda, Inc. | 2015-12-31 |