Giraffe OmniBed Carestation CS1 — Class II medical device recall Z-0281-2020
Ongoing recall by GE Healthcare, LLC, reported 2019-11-13, distributed nationwide. Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to
| Recall number | Z-0281-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-07-26 |
| Classified | 2019-11-04 |
| Reported by FDA | 2019-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, DE, FR, KR |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07067711190607, 07068811190610, 07069411190611, 07070911190612, 07072911190616 |
| Serial numbers | TABY70638, TABY70642, TABY70644, TABY70645, TABY70646, TABY70647, TABY70648, TABY70649, TABY70650, TABY70651, TABY70652, TABY70653, TABY70654, TABY70655, TABY70656, TABY70657, TABY70658, TABY70659, TABY70660, TABY70661, TABY70662, TABY70663, TABY70664, TABY70665, TABY70666 and 55 more |
| Model numbers | 2082844-001 |
Product
Giraffe OmniBed Carestation CS1 - Product Usage: The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo regulate based on their own physiology.
Reason for recall
Fasteners potentially torqued to a value less than the specified value and can potentially cause the canopy to become detached and fall.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0281-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.