The Recall Desk
HighFDA (Devices)·Z-0487-2018·Announced 2018-02-07

GE Healthcare CARESCAPE Central Station software recall for communication issues

GE Healthcare is recalling CARESCAPE Central Station software version 2.0.2 because units may experience unexpected network communication issues after boot-up or restart.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device software defect that could disrupt patient monitoring and alarm systems. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Medical Systems Information Technologies, Inc. is recalling 1,803 units of CARESCAPE Central Station (CSCS) software version 2.0.2. The software is intended to collect and display physiological, patient demographic, and other non-medical information from a network, including alarm annunciation and printing capabilities.

The recall was initiated because the affected software units may experience unexpected "NO COMM" (No Communication) and network communication issues after boot-up or system restart. This defect could potentially disrupt the display of patient data or alarm notifications.

The affected units were distributed worldwide, including in the United States and numerous other countries. Healthcare facilities should contact GE Healthcare for instructions on how to resolve the communication issues.

The recalled product

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. Physiologi
Affected units
1,803

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model
  • Catalogue
  • or Code/ UDI/ Mfg. Lot or Serial Number Model

Distribution

Distributed nationwide across the United States.