Recall Z-0524-2013— GE Healthcare, LLC

Name: FDA recall Z-0524-2013
Creator: U.S. Food and Drug Administration
Published: 2012-02-17

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2012-02-17, terminated 2013-12-03. It names one FDA 510(k) clearance: K071073. Product: GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.. Reason: GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-02-17
Terminated: 2013-12-03
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K071073 — SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGe Medical Systems Information Technologies·cleared 2007-05-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.

Reason for recall

GE Healthcare became aware of two issues with the Patient Data Module using Version 2.0 software that may impact patient care.

Data sourced from openFDA. This site is unofficial and independent of the FDA.