CARESCAPE ONE — Class II medical device recall Z-2750-2020
Terminated recall by GE Healthcare, LLC, reported 2020-08-12, distributed nationwide. CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs
| Recall number | Z-2750-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-06-22 |
| Classified | 2020-08-04 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2024-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, BO, BR, CA, CH, CL, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HU, ID, IE, IL, IN, IT, JP, KE, KR, KW, LB, LT, LV, MA, MT, MY, NL, NO, NZ, OM, PA, PH, PK, PL, PT, QA, RS, RU, SA, SE, SG, SI, SK, TH, ZA |
| Quantity | 8,414 units |
| Serial numbers | SNA18140004SA, SNA18140005SA, SNA18140007SA, SNA18140024SA, SNA18240025SA, SNA18240026SA, SNA18240030SA, SNA18240032SA, SNA18240044SA, SNA18240051SA, SNA18240054SA, SNA18240079SA, SNA18250010SA, SNA18250012SA, SNA18250017SA, SNA18250023SA, SNA18250026SA, SNA18250033SA, SNA18250034SA, SNA18250036SA, SNA18250044SA, SNA18250061SA, SNA18250072SA, SNA18250075SA, SNA18250078SA and 271 more |
| Model numbers | 2087075-001 |
Product
CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
Reason for recall
CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.
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-2750-2020. 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.