Reported Feb 7, 2018 · Terminated
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to…
GE Medical Systems Information Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems Information Technologies, Inc. · 8200 W Tower Ave · Milwaukee, WI · 53223-3219
Is this the product you have?
- 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.
- Lot codes and dates
- Model, Catalogue, or Code/ UDI/ Mfg. Lot or Serial Number Model, Catalogue or Code # UDI # Mfg. Lot or Serial #
1,572 of 1,572 codes
2092670-001-51015700840682109666SKN16290004SASKN16290004SA2092670-001-51085400840682109666SKN17090034SASKN17090034SA2092670-001-51085400840682109666SKN17270013SASKN17270013SA2092670-001-51085400840682109666SKN17270014SASKN17270014SA2092670-001-51613800840682109666SKN16440004SASKN16440004SA2092670-001-51613800840682109666SKN16440005SASKN16440005SA2092670-001-51613800840682109666SKN17130042SASKN17130042SA2092670-001-51613800840682109666SKN17130076SASKN17130076SA2092670-001-51613800840682109666SKN17130082SASKN17130082SA2092670-001-51613800840682109666SKN16440003SASKN16440003SA2092670-001-51613800840682109666SKN17200095SASKN17200095SA2092670-001-51613800840682109666SKN17210183SASKN17210183SA2092670-001-51613800840682109666SKN17210184SASKN17210184SA2092670-001-51613800840682109666SKN17300018SASKN17300018SA2092670-001-51613800840682109666SKN17350035SASKN17350035SA2092670-001-51613800840682109666SKN17350036SASKN17350036SA2092670-001-51613800840682109666SKN17390030SASKN17390030SA2092670-001-51613800840682109666SKN17390031SASKN17390031SA2092670-001-51613800840682109666SKN17400032SASKN17400032SA2092670-001-51613800840682109666SKN17400033SASKN17400033SA
- Model, Catalogue, or Code/ UDI/ Mfg. Lot or Serial Number Model, Catalogue or Code # UDI # Mfg. Lot or Serial #
- Amount recalled
- 1803 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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