510(k) K162012 ยท DXJ Display, Cathode-Ray Tube, Medical
CARESCAPE Central Station V2
| Applicant | GE Healthcare, Milwaukee WI, US |
| Decision | Substantially Equivalent, Sep 15, 2016 |
| Received | Jul 21, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | GE Medical Systems Information Technologies Inc Carescape Central Station
CSCS V3 MAS800 Desktop
Part Number 5867474-04, 5867474-13
Product code STU
CSCS V3 MAI800 Integrated
Part Number 5867474-03
Product Code STV Open, Classified |
DQK | None listed |
| Oct 21, 2025 | Wipro GE Healthcare Private Ltd. GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube Open, Classified |
DXJ | None listed |
| Oct 21, 2025 | Wipro GE Healthcare Private Ltd. GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube Open, Classified |
DXJ | None listed |
| Jun 13, 2022 | GE Healthcare, LLC CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001.
Update 3/10/2023: The following FRU and display part numbers have been added as affected devices:
(1) Part #2082294-0 Open, Classified |
DXJ | None listed |
| Mar 16, 2022 | GE Healthcare, LLC GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001. Open, Classified |
DXJ | None listed |
| Jan 25, 2018 | GE Medical Systems Information Technologies, Inc. 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 physio Terminated |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.