Recall Z-1779-2017— GE Healthcare, LLC

Name: FDA recall Z-1779-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-10

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2017-03-10, terminated 2018-03-12. It names one FDA 510(k) clearance: K150087. Product: Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.. Reason: GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-03-10
Terminated: 2018-03-12
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K150087 — Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS·cleared 2015-03-04

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

Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.

Reason for recall

GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist search response time is slow. This issue is limited to certain Vivid Ultrasound systems and can result in the incorrect patient information showing on the screen during the exam. If not detected by the operator, images from the actual (intended) patient will be stored under the incorrect patient after the exam. This issue could lead to misdiagnosis. There have been no injuries reported because of this issue.

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