Giraffe Incubator with installed Servo Oxygen module — Class II medical device recall Z-2236-2020
Terminated recall by GE Healthcare, LLC, reported 2020-06-24, distributed nationwide. Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen leve
| Recall number | Z-2236-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-04-28 |
| Classified | 2020-06-15 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2024-09-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BM, CA, CH, CL, CN, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JO, JP, KR, KW, LT, LV, MA, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TN, TR, UA, UY, VE, ZA |
| Quantity | 5,883 units |
| Model numbers | 6600-0233-850 |
Product
Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
Reason for recall
Potential for certain Giraffe Incubators and Giraffe OmniBeds to deliver a different environmental oxygen level than what is displayed by the device, if a certain optional component referred to as the Servo Oxygen Module is installed.
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-2236-2020. 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.