GE Healthcare CARESCAPE Central Station — Class II medical device recall Z-0808-2022
Ongoing recall by GE Healthcare, LLC, reported 2022-03-23, distributed nationwide. If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in
| Recall number | Z-0808-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2022-01-28 |
| Classified | 2022-03-16 |
| Reported by FDA | 2022-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GH, HK, HU, ID, IE, IL, IN, IQ, IS, IT, JO, JP, KE, KR, KW, LB, LT, MX, MY, NG, NL, NO, PA, PH, PK, PL, QA, RO, SA, SE, SG, SK, TH, TN, TR, TW, UY, VN, ZA |
| Quantity | 10,445 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00840682109604, 00840682109666 |
| Model numbers | 2082278-001, 2082279-001, MAS700 |
Product
GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
Reason for recall
If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms.
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-0808-2022. 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.