GE HEALTHCARE CARESCAPE Central Station — Class II medical device recall Z-0487-2018
Terminated recall by GE Medical Systems Information Technologies, Inc., reported 2018-02-07, distributed nationwide. CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communicat
| Recall number | Z-0487-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies, Inc., Milwaukee, WI, United States |
| Recall initiated | 2018-01-11 |
| Classified | 2018-01-29 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2021-07-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CR, CZ, DE, DK, DZ, EG, ES, FI, FR, GB, HU, ID, IE, IN, IQ, IS, IT, JO, JP, KR, KW, LB, MX, NL, NO, NZ, PL, QA, SA, SE, SG, SK, TH, TR, TW, UY, VN, ZA |
| Quantity | 1,803 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00840682109604, 00840682109666 |
| Serial numbers | 00840682109666SKN16290004SA, 00840682109666SKN16440003SA, 00840682109666SKN16440004SA, 00840682109666SKN16440005SA, 00840682109666SKN17090034SA, 00840682109666SKN17130042SA, 00840682109666SKN17130076SA, 00840682109666SKN17130082SA, 00840682109666SKN17200095SA, 00840682109666SKN17210183SA, 00840682109666SKN17210184SA, 00840682109666SKN17260058SA, 00840682109666SKN17270013SA, 00840682109666SKN17270014SA, 00840682109666SKN17270016SA, 00840682109666SKN17270017SA, 00840682109666SKN17270039SA, 00840682109666SKN17290007SA, 00840682109666SKN17300011SA, 00840682109666SKN17300018SA, 00840682109666SKN17300024SA, 00840682109666SKN17300025SA, 00840682109666SKN17300026SA, 00840682109666SKN17300027SA, 00840682109666SKN17300028SA and 475 more |
Product
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.
Reason for recall
CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
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-0487-2018. 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.